Model Curriculum

Quality Control Chemist

SECTOR: LIFE SCIENCES
SUB-SECTOR: PHARMACEUTICAL
OCCUPATION: QUALITY
REF ID: LFS/ Q 1301 Ver1.0
NSQF LEVEL: LEVEL 5
 TABLE OF CONTENTS

1. Curriculum 01

2. Trainer Prerequisites 11

3. Annexure: Assessment Criteria 12

Quality Control Chemist
CURRICULUM / SYLLABUS

This program is aimed at training candidates for the job of a “Quality Control Chemist”, in the “Life Sciences”
Sector/Industry and aims at building the following key competencies amongst the learner

Program Name Quality Control Chemist

Qualification Pack Name & Quality Control Chemist LFS/ Q 1301 Ver1.0
Reference ID. ID
Version No. 1.0 Version Update Date 24–12 – 2015

Pre-requisites to Training B. Pharma / B. Sc. with Chemistry major subject or Analytical Chemistry (Preferable)

Training Outcomes After completing this programme, participants will be able to:
• Gain knowledge about Life Sciences Industry, Legal and Regulatory
framework and Pharmacopeia to enable him/herself for establishing the
Industry Standards in his/her performance
• Gain Scientific knowledge and skills about application of Basics of
Chemistry, chromatography and separation science in instrumental
analysis of Pharmaceutical Products as well as gain Procedural Knowledge
and Quality skills for Sample Preparation and Sample Handling and Skills to
perform Quality Check (Inspection and Analysis), to enable him/herself
able to perform routine analysis in lab while ensuring compliance with
GDP, GMP & GLP and organizational SOP
• Gain Knowledge of basic statistics and hands on Knowledge of various
statistical tools and techniques to perform statistical analysis of QC results
in lab while ensuring compliance with GDP, GMP & GLP and organizational
SOP
• Operate analytical Equipment and Instruments like Gas Chromatography
(GC), High Performance Liquid Chromatography (HPLC), Fourier Transfer-
Infrared (FT-IR), Inductively Coupled Plasma (ICP), Auto-Titration, UV-Visible
mass spectrophotometer detection, stability chambers, BOD incubators,
Photoflourometer
• Perform routine analysis in lab while ensuring compliance with GMP & GLP
and carry out Quality Checks in the Quality Control process
• Follow the norms of Good Documentation Practice, online documentation
system, various SOP’s and reporting formats, GMP/ GLP guidelines relating
to the required information capturing, reporting and documentation to
meet the quality standards.
• Gain Knowledge of QMS for Quality Control, norms for global standards
like cGMP, ISO, GLP, GDP. Skills to operate a Laboratory Management
Information System
• Carryout reporting and documentation as per quality standards and SoPs

Quality Control Chemist 1

Program Name Quality Control Chemist

• Participate in audits as a QC team member and generate the responses for

audit queries. Ability to deal with potential risks and challenges for quality
and data integrity.
• Maintain a healthy, safe and secure working environment at the
pharmaceutical manufacturing shop floor, Laboratory and area around as
per EHS requirement and Industrial practices. He/ she become capable of
managing emergency procedures.
• Ensure routine maintenance and cleanliness at work area.
• Coordinate and support with Supervisor, cross functional teams and within
the team for various functional activities
• Practice Professional Skills at work; like Decision Making, Planning &
Organizing, Customer Centricity, Problem Solving (including trouble
shooting), Analytical Thinking, Critical Thinking

Quality Control Chemist 2

This course encompasses Six (6) out of Six (6) National Occupational Standards (NOS) of “Quality Control Chemist- Life
Sciences (LFS/Q 1301 Ver1.0)” Qualification Pack issued by “Life Sciences Sector Skill Development Council, India”.

Sr. Module Key Learning Outcomes Equipment Required

No.
1 Orientation Module • Understand Brief outline of Life Sciences Participant Manual, Power
Industry, its sub-sectors point presentation, Case
Theory Duration • Gain knowledge of Regulatory Authorities and Studies, Computer system,
(hh:mm) LCD Projector & Screen/
Government Policies, rules and Regulations
LCD Monitor, Mike, Sound
10:00 and their impact on manufacturing in Life
System, Laser Pointer,
Sciences Industry
White/ Black Board, White
Practical Duration • Know the Standards for Manufacturing in Life Board Marker/ chalk,
(hh:mm) Sciences like CGMP, ISO, GLP, GDP etc. Gain duster, flip charts
00:00 orientation with Pharmacopeia and how to
read them

Corresponding NOS • Know about Existing Organisation in Life

Code Sciences Industry (in context of
LFS/N0301, LFS/N0314 Large/Medium/ Small Enterprises): Their
Organization Structure and Benefits.
LFS/N0302 Orientation on typical manufacturing and
Quality function in a Life Sciences
organization.
• Know about Role of a Quality Control Chemist
and required skills and knowledge (As per
Qualification Pack) and its Career Path
2. Overview of • Know about Fundamental Science in API Participant Manual, Power
Production Process Production including Size Separation, Mixing point presentation, Case
for Life Sciences and homogenization Process, Mass Transfer, Studies, Computer system,
Industry Fluid Flow, Heat Transfer, Size Reduction, Role LCD Projector & Screen/
of API in typical Pharmaceutical LCD Monitor, Mike, Sound
Theory Duration Manufacturing and role of API particle size in System, Laser Pointer,
(hh:mm) formulations, Knowledge on Critical Quality White/ Black Board, White
Attributes (CQA), Critical Process Parameters Board Marker/ chalk,
10:00
(CPP) and Critical Process Controls(CPC). duster, flip charts,
• Know about Basics of Formulations including Manufacturing Equipment
Practical Duration Route of Drug Administration and Various models/ diagrams (API &
(hh:mm) Dosage Forms like Oral Solid Dosage, Liquid Formulations)
06:00 Oral Dosage, Sterile Dosage, Dermatological
Dosage and their relevant benefits, Assay
calculation procedure and assay role in
Corresponding NOS
formulation, Standard weight procedure or
Code
standard quantity effect in formulation.
LFS/N0301, LFS/N0302,
• Know about Quality Management System for
LFS/N0320
Production in Life Sciences Industry including
LFS/N0314
its introduction and importance, QC and QA
Systems, Detail aspects of CGMP, GLP, ISO
with reference o quality control
3. Fundamentals of • Learn and apply Basics of Pharmaceutical Participant Manual, Power
Instrumental Analysis Science and Chemistry inclusive of Organic point presentation, Case
for Life Sciences Nomenclature System, Organic Reaction Studies, Computer system,
Industry Mechanism, and Basic Analytical Chemistry LCD Projector & Screen/

Quality Control Chemist 3

Sr. Module Key Learning Outcomes Equipment Required
No.
fundamentals including balancing chemical LCD Monitor, Mike, Sound
Theory Duration equations, chemical equilibria, acid and base System, Laser Pointer,
(hh:mm) chemistry, stoichiometric calculations, White/ Black Board, White
10:00 reduction and oxidation chemistry and Board Marker/ chalk,
interaction of light with matter. duster, flip charts, Periodic
• Know and apply the detailed understanding Table of Elements,
Practical Duration Chemistry lab equipment
(hh:mm) of basic principles of Separation Sciences,
critical system parameters and their Industrial and glassware, gloves, half
02:00 use in Quality Control analysis for Life Sciences face mask, apron
Industry
Corresponding NOS
Code
LFS/N0301, LFS/N0320

4. Sample Preparation, • Know and apply the basics of Sample Syringes (2ml, 5ml, 10ml),
preservation and Preparation, preservation and storage, Mortor and Pessel (Type:
Storage Handling Glassware in Laboratory, Calibration Silica, SS-316L, Agate,
of Glassware. Guidelines for Weighing and Granite), Halogen Moisture
Theory Duration measuring the samples, safety precautions Analyzer, Seive Shaker,
(hh:mm) while handling sample and understanding the Seive meshes (All grade
toxicity and carcinogenicity while handling levels like 100, 150, 200,
07:00
critical samples. 250 etc,..), Motor grinder,
Muffle Furnace, Silica &
• Know about Standards and guidelines for
Practical Duration Platinum Crucibles, Muffle
sample handling in Pharmaceutical and
(hh:mm) Furnace, Loss on Drying
Biopharmaceutical Industry and perform
04:00 Machine with Vaccum,
sample handling and preparation.
pressure gauge meter,
• Gain detailed knowledge of Good Storage Refractometer, Polarimeter,
Corresponding NOS Practice, how to know stability of sample and Auto titrator, Melting point,
Code process of sample stabilization, before storage Capillary tubes, TLC
LFS/N0301, LFS/N0103 of sample and apply the learned practices chamber, Brookfiled
while sample storage. Viscometer, Black particle
size analyzer, Density
meter,Bulk density and
Tapped density tester,
Friabilator, Vernier calipers,
Micrometer screw gauge,
Karl Fisher Apparatus
(Make: Metrom), Particle
Size Analyzer (Make:
Malvern Master 2000),
Hardness Tester, Labeling
Machine, Laboratory
Microscopes(40X and
100X), Barcode scanner,
Torque tester, Induction
cap sealer, Bursting
strength, Pin hole tester,
Differential scanning
calorimeter, Analytical
balance with printer,

Quality Control Chemist 4

Sr. Module Key Learning Outcomes Equipment Required
No.
Pipettes (1mL, 2mL, 5
ml/10 ml), Sonicators, Hot
air oven, Rotary shaker
water bath, Glassware
drying oven, Cleaning
agents (soap/alconox etc),
Centrifuge , Centrifuge
tubes, pH meter ,
conductivity meter, Scale,
Magnetic stirrers, Hot plate
with magnetic stirrer, LOD
bottles
Desicattor, Droppers,
Vortex mixer, Lab equipped
with Fume Hoods,
Glassware for Lab, Burrette
stand with white tile
5. Operating Knowledge • Gain detailed knowledge about Molecular, UV Analyser (Make: Perkin
of Analytical Atomic near Infrared spectroscopy and elmer/shimadzu/Thermo),
Instruments Vibrational spectroscopy and the analysis of FT-IR (Make:
metals and apply leraning while operating Shimadzu/Thermo), HPLC
Theory Duration analytical instruments. (Make:
(hh:mm) Agilent/Waters/Shimadzu),
• Gain Conceptual Scientific Knowledge and
Mobile phase filteration kit
34:00 skills and operate analytical Equipment and
with filters (MilliQ) with
Machinery like Fourier Transfer-Infrared (FT-
vaccum motor, Milli-Q /
IR), Inductively Coupled Plasma (ICP), Auto-
Practical Duration TKA water for HPLC,
Titration, UV-Visible mass spectrophotometer
(hh:mm) Syringe Filters (6,6-
detector, pH meter.
34:00 Nylon,PVTF, PVDFE, PTFE
• Gain knowledge and skills about etc..), Specific optical
Chromatography including Basic principles of rotation Analyser (Make:
Corresponding NOS chromatography, Thin Layer Chromatography, Rudolph Autopol V/ Jasco
Code Gas Chromatography and Liquid 2000 or 3000), HPLC vials,
LFS/N0301 Chromatography, High performance Liquid Crimpers, Dissolution filters
Chromatography, Preparatory, High ( 1 micron), Gas
performance Liquid Chromatography. chromatographer , GC vials,
• Operate analytical Equipment and GC injection needle, hplc
Instruments like Gas Chromatography (GC), columns, gc columns,
High Performance Liquid Chromatography Dissolution Apparatus, DT
(HPLC). Apparatus

6. Perform Quality • Learn and Perform Quality Check (Inspection Syringes (2ml, 5ml, 10ml),
Checks in Quality and Analysis) in QC, compare results with UV Analyser (Make: Perkin
Control Process statistical limits, Calibrations, IQ, OQ, PQ and elmer/shimadzu/Thermo),
techniques for improving instrumental FT-IR (Make:
Theory Duration analysis. Handle Exceptions. Operate the Shimadzu/Thermo), Mortor
(hh:mm) instruments like stability chambers, BOD and Pessel (Type: Silica, SS-
incubators and Photo flouro meter. 316L, Agate, Granite),
14:00
Knowledge of QC analysis Checklist for all Halogen Moisture Analyzer,
relative instruments. Seive Shaker, Seive meshes
(All grade levels like 100,

Quality Control Chemist 5

Sr. Module Key Learning Outcomes Equipment Required
No.
Practical Duration • Know about and Productivity norms and 150, 200, 250 etc,..), Motor
(hh:mm) calculate the overall equipment efficiency grinder, Muffle Furnace,
06:00 (OEE), practice Techniques of improving Silica & Platinum Crucibles,
productivity (Lean and 6 sigma), Techniques Muffle Furnace, Loss on
to control the rejects. Learn and apply Drying Machine with
Corresponding NOS Techniques to control the breakdown, Vaccum, pressure gauge
Code Handling of market complaints, Deviation, meter, Refractometer,
LFS/N0320, LFS/N0314 incident and change control procedure and Polarimeter, Auto titrator,
Required Documentation practices by QMS, Melting point, Capillary
CGMP. tubes, TLC chamber,
Brookfiled Viscometer,
• Carry out Statistical Analysis of Laboratory
Black particle size analyzer,
data: Gain Knowledge of Calculations and Use
Density meter,Bulk density
of QC Statistics like Levey-Jennings Charts &
and Tapped density tester,
Westgard Rules, CV, Comparative Evaluations,
Friabilator, Vernier calipers,
CVR, SDI.
Micrometer screw gauge,
• Learn and apply Fundamentals of Advance QC Karl Fisher Apparatus
approaches like Quality by Design and Process (Make: Metrom), Particle
Analytical Technology, Method Transfer Size Analyzer (Make:
Process and how to manage the Quality Risk. Malvern Master 2000),
• Practice Practical problem solving/ trouble Hardness Tester, Labeling
shooting in QC Analysis. Machine, Laboratory
Microscopes(40X and
100X), Barcode scanner,
Torque tester, Induction
cap sealer, Bursting
strength, Pin hole tester,
Differential scanning
calorimeter, Analytical
balance with printer,
Pipettes (1mL, 2mL, 5
ml/10 ml), Sonicators, Hot
air oven, Rotary shaker
water bath, Glassware
drying oven, Cleaning
agents (soap/alconox etc),
Centrifuge , Centrifuge
tubes, pH meter ,
conductivity meter, Scale,
Magnetic stirrers, Hot plate
with magnetic stirrer, LOD
bottles
Desicattor, Droppers,
Vortex mixer, Lab equipped
with Fume Hoods,
Glassware for Lab, Burrette
stand with white tile, HPLC
(Make:
Agilent/Waters/Shimadzu),
Mobile phase filteration kit
with filters (MilliQ) with

Quality Control Chemist 6

Sr. Module Key Learning Outcomes Equipment Required
No.
vaccum motor, Milli-Q /
TKA water for HPLC,
Syringe Filters (6,6-
Nylon,PVTF, PVDFE, PTFE
etc..), Specific optical
rotation Analyser (Make:
Rudolph Autopol V/ Jasco
2000 or 3000), HPLC vials,
Crimpers, Dissolution filters
( 1 micron), Gas
chromatographer , GC vials,
GC injection needle, hplc
columns, gc columns,
Dissolution Apparatus, DT
Apparatus
7. Documentation for • Learn the concept and practical skills for Work Participant Manual, Power
Quality Control Planning of Quality Control and required point presentation, Case
documentation in various Quality Control Studies, Computer system,
Theory Duration Process like reporting LCD Projector & Screen/
(hh:mm) defects/problem/incidents/quality issues/test LCD Monitor, Mike, Sound
results considering Data integrity aspects and System, Laser Pointer,
12:00
follow the learnings while documentation for White/ Black Board, White
quality control. Board Marker/ chalk,
Practical Duration • Learn and follow the detailed concepts of duster, flip charts, Formats
(hh:mm) Good Documentation Practices and of Lab Notebook, Log
10:00 Knowledge about importance of Data books, sample of graphs
Integrity and how to complete and analytical reports
Corresponding NOS documentation in line with Good Laboratory
Code Practices and Good Manufacturing Practices.
LFS/N0301, LFS/N0302, • Provide a detailed response to an audit /
LFS/N0314, LFS/N0320 process related query from any cross-
functional team and Quality assurance team.
• Know and follow generic Organizational
Policy & various internal Process relevant for
QC Chemist like reporting unresolved issues,
hazards, escalations, test point recording
requirements etc.
• Learn and practice Related Core Skills and
Professional Skills: Reading, writing, listening
and speaking, Critical thinking, problem
solving, decision making, customer centricity,
plan and organizing, Analytical thinking.
8. Maintain a healthy, • Learn and follow the Basic Concepts of Safety Half Face Mask, Full Face
safe and secure including Hazards, Accidents, Safety Signs and Mask, Various Cartridges,
working environment Signals and Henriech Pyramid and use the PPE Safety Goggles, Safety
in the pharmaceutical and safety tools like eye shower etc. Shoes, Gum Boots,
manufacturing facility Chemical Absorbent, Self
• Know about Water Systems at Plant,
and laboratory Contained Breathing
Engineering related tools and techniques to
Apparatus, PVC Apron,
operate the machine safely.
Theory Duration Gloves(Nitrile, {Heat, acid,

Quality Control Chemist 7

Sr. Module Key Learning Outcomes Equipment Required
No.
(hh:mm) • Use Material Data Safety Sheet, follow the chemical} resistant,
16:00 Process of Safety Analysis, Handle Hazardous washing etc..), Lab Coat,
Material in Lab, know and follow Fire Safety Surgical Gloves (in
concepts and how to act in case of Fire Microbiology), Eye washer
Practical Duration Emergency at shop floor. Know about various with sprinkler/ Manual
(hh:mm) PPEs used in different production operations bottle eye washer, Co2
10:00 and do Job Safety Analysis for Various type Fire Extinguisher, ABC
production machines/ equipment. Type Fire Extinguisher
Corresponding NOS • Learn and follow the Basic Concepts and
Code practical skills for managing Emergency
LFS/N0101 Procedures and how to do first aid.
• Practice Related Core Skills and Professional
Skills: Reading, writing, listening, speaking,
Plan and organize, Critical thinking, problem
solving, decision making, customer centricity.
9. Ensure Cleanliness in • Gain Knowledge of different Material, Various types of cleaning
the work area. chemicals and equipment and their cleaning material, chemicals,
procedure as per manufacturer’s guide. cleaning equipment, Half
Theory Duration Face Mask, Full Face Mask,
• Gain Knowledge about Electronic and Optical
(hh:mm) Various Cartridges, Safety
Sensors in laboratory equipment and their
Goggles, Safety Shoes,
08:00 operations as per the manual.
Gum Boots, Chemical
• Know and Follow methodology for storage Absorbent, Self Contained
Practical Duration area inspection with methods and materials Breathing Apparatus, PVC
(hh:mm) required for cleaning variety of surfaces and Apron, Gloves(Nitrile, {Heat,
08:00 equipment, methods to check the treated acid, chemical} resistant,
surface and equipment on completion of washing etc..), Lab Coat,
cleaning, disposal methods for waste, used/ Surgical Gloves (in
Corresponding NOS unused solutions and relevant SOP, Microbiology), Eye washer
Code Procedures for reporting any unidentified with sprinkler/ Manual
LFS/N0103 soiling and Escalation procedures for soils or bottle eye washer, Co2
stains that could not be removed. type Fire Extinguisher, ABC
• Practice Related Core Skills and Professional Type Fire Extinguisher
Skills: Reading, writing, listening, speaking,
Plan and organize, Critical thinking, problem
solving, decision making, customer centricity.
10. Coordinate with • Manage Supervisor- Reportee Relationship Power point presentation,
Supervisor, within including identify Partnering Opportunities at Case Studies, Computer
team and cross work; Know and follow General reporting system, LCD Projector &
functional the teams. process, protocol and escalation policy and Screen/ LCD Monitor, Mike,
Importance of reports and communication Sound System, Laser
Theory Duration with Supervisor. Pointer, White/ Black Board,
(hh:mm) White Board Marker/ chalk,
• Apply techniques for Collaborating with Other
duster, flip charts, Sample
16:00 Groups and Divisions.
Audit Report and Sample
• Learn and follow the conceptual and practical Responses
skills required by QC Chemist in Audits:
• Importance of CGMP/ GLP/ GDP/QMS/ SOP
Practical Duration related documentation

Quality Control Chemist 8

Sr. Module Key Learning Outcomes Equipment Required
No.
(hh:mm) • Method to Respond to Audit Queries How to
10:00 Face Internal Audit Interactions
• Use of IT in communication and coordination.
Corresponding NOS • Practice Related Core Skills and Professional
Code Skills: Reading, writing, listening, speaking,
LFS/N0302, LFS/N0314 Analytical thinking, problem solving, decision
making, customer centricity.
11 Information • Apply Basic Computer Skills (Ms Office, Participant Manual, Power
Technology Skills Internet)+ Typing Practice at Work. point presentation,
Computer Lab, LCD
• Handle different software’s used to operate
Theory Duration Projector & Screen/ LCD
the QC instruments.
(hh:mm) Monitor, Mike, Sound
• Gain and apply Knowledge about 21 CFR Part System, Laser Pointer,
16:00 11 compliance system and its requirements. White/ Black Board, White
Board Marker/ chalk, duster
Practical Duration
(hh:mm)
20:00

Corresponding NOS
Code
LFS/N0314
12. Internship • Sample Preparation and sample handling. Internship Monitoring
Report
• Instrument handling for Quality Control and
Theory Duration how to maintain the work area clean.
(hh:mm)
• Maintain a healthy, safe and secure working
00:00 environment in the pharmaceutical facility of
manufacturing /testing/ analysis / research
Practical Duration laboratory.
(hh:mm) • Coordinate with Shift Supervisor, cross
200:00 functional teams especially QA, Production,
Maintenance and SCM and within the team.
Corresponding NOS • Carryout reporting and documentation to
Code meet quality standards.
LFS/N0301
LFS/N0320,
LFS/N0101,
LFS/N0103
LFS/N0302
LFS/N0314
Total Duration Unique Equipment Required:
Participant Manual, Power point presentation, Case Studies, Computer system, LCD
Projector & Screen/ LCD Monitor, Mike, Sound System, Laser Pointer, White/ Black
Board, White Board Marker/ chalk, duster, flip charts, Manufacturing Equipment
models/ diagrams (API & Formulations), Periodic Table of Elements, Chemistry lab

Quality Control Chemist 9

Sr. Module Key Learning Outcomes Equipment Required
No.
Theory Duration equipment and glassware, gloves, half face mask, apron, Syringes (2ml, 5ml, 10ml),
(hh:mm) Mortor and Pessel (Type: Silica, SS-316L, Agate, Granite), Halogen Moisture
153:00 Analyzer, Seive Shaker, Seive meshes (All grade levels like 100, 150, 200, 250 etc,..),
Motor grinder, Muffle Furnace, Silica & Platinum Crucibles, Muffle Furnace, Loss on
Drying Machine with Vaccum, pressure gauge meter, Refractometer, Polarimeter,
Practical Duration Auto titrator, Melting point, Capillary tubes, TLC chamber, Brookfiled Viscometer,
(hh:mm) Black particle size analyzer, Density meter, Bulk density and Tapped density tester,
310:00 Friabilator, Vernier calipers, Micrometer screw gauge, Karl Fisher Apparatus (Make:
Metrom), Particle Size Analyzer (Make: Malvern Master 2000), Hardness Tester,
Labeling Machine, Laboratory Microscopes(40X and 100X), Barcode scanner,
Torque tester, Induction cap sealer, Bursting strength, Pin hole tester, Differential
scanning calorimeter, Analytical balance with printer, Pipettes (1mL, 2mL, 5 ml/10
ml), Sonicators, Hot air oven, Rotary shakerwater bath, Glassware drying oven,
Cleaning agents (soap/alconox etc), Centrifuge , Centrifuge tubes, pH meter ,
conductivity meter, Scale, Magnetic stirrers, Hot plate with magnetic stirrer, LOD
bottlesDesicattor, Droppers, Vortex mixer, Lab equipped with Fume Hoods,
Glassware for Lab, Burrette stand with white tile, UV Analyser (Make: Perkin
elmer/shimadzu/Thermo), FT-IR (Make: Shimadzu/Thermo), HPLC (Make:
Agilent/Waters/Shimadzu), Mobile phase filteration kit with filters (MilliQ) with
vaccum motor, Milli-Q / TKA water for HPLC, Syringe Filters (6,6-Nylon,PVTF, PVDFE,
PTFE etc..), Specific optical rotation Analyser (Make: Rudolph Autopol V/ Jasco 2000
or 3000), HPLC vials, Crimpers, Dissolution filters ( 1 micron), Gas chromatographer
, GC vials, GC injection needle, hplc columns, gc columns, Dissolution Apparatus,
DT Apparatus, Formats of Lab Notebook, Log books, sample of graphs and
analytical reports, Various types of cleaning material, chemicals, cleaning
equipment, Half Face Mask, Full Face Mask, Various Cartridges, Safety Goggles,
Safety Shoes, Gum Boots, Chemical Absorbent, Self-Contained Breathing
Apparatus, PVC Apron, Gloves(Nitrile, {Heat, acid, chemical} resistant, washing
etc..), Lab Coat, Surgical Gloves (in Microbiology), Eye washer with sprinkler/
Manual bottle eye washer, Co2 type Fire Extinguisher, ABC Type Fire Extinguisher,
Sample Audit Report and Sample Responses, Computer Lab, Internship Monitoring
Report

Grand Total Course Duration: 463Hours 00 Minutes

(This syllabus/ curriculum has been approved by Life Sciences Sector Skill Development Council.)

Quality Control Chemist 10

Trainer Prerequisites for Job role: “Quality Control Chemist” mapped to
Qualification Pack: “LFS/ Q 1301 Ver1.0”

Sr.
Area Details
No.
1 Job Description To deliver accredited training service, mapping to the curriculum detailed
above, in accordance with the Qualification Pack “LFS/Q1301 Ver1.0”.
2 Personal Attributes Aptitude for conducting training, and pre/ post work to ensure
competent, employable candidates at the end of the training. Strong
communication skills, interpersonal skills, ability to work as part of a team;
a passion for quality and for developing others; well-organised and
focused, eager to learn and keep oneself updated with the latest in the
mentioned field.
3 Minimum Educational B. Pharma / B. Sc. with Chemistry major subject or Analytical Chemistry
Qualifications (Preferable)
4a Domain Certification Certified for Job Role: “Quality Control Chemist” mapped to QP: “LFS/Q
1301 Ver1.0”. Minimum accepted score is 80% as per LSSSDC guidelines.
4b Platform Certification Recommended that the Trainer is certified for the Job Role: “Trainer”,
mapped to the Qualification Pack: “SSC/Q1402”. Minimum accepted score
is 80% as per LSSSDC guidelines.
5 Experience Preferably Minimum Four (4) years’ experience in life sciences
(Pharmaceutical/ Biopharmaceutical) Quality occupation for non-trained
and non-qualified talent
Or
Minimum Two (2) years’ experience with Quality Control Chemist Level-5
qualified

Quality Control Chemist 11

Annexure: Assessment Criteria

Assessment Criteria for Quality Control Chemist

Job Role Quality Control Chemist
Qualification Pack LFS/ Q 1301 Ver1.0
Sector Skill Council Life Sciences Sector Skill Development Council

Sr.
Guidelines for Assessment
No.
1 Criteria for assessment for each Qualification Pack will be created by the Sector Skill Council. Each
Performance Criteria (PC) will be assigned marks proportional to its importance in NOS. SSC will also lay down
proportion of marks for Theory and Skills Practical for each PC
2 The assessment for the theory part will be based on knowledge bank of questions created by the SSC
3 Individual assessment agencies will create unique question papers for theory part for each candidate at each
examination/training centre (as per assessment criteria laid out in Qualification Pack)
4 Individual assessment agencies will create unique evaluations for skill practical for every student at each
examination/training centre based on the assessment criteria laid out in qualification pack
5 To pass the Qualification Pack , every trainee should score a minimum of 70% aggregate in all NOS and a
minimum of 50% in every NOS
6 In case of successfully passing only certain number of NOS's, the trainee is eligible to take subsequent
assessment on the balance NOS's to pass the Qualification Pack

Quality Control Chemist 12

 Marks Allocation
Total Out Of Theory Skills
Marks Practical
(300)
LFS/N0301 PC1. perform all the routine quality check 100 3 1 2
(Perform routine activities and validations satisfactorily, including
analysis in lab checking for sample authenticity, appropriate
while ensuring storage of chemicals/ reagents, maintaining
compliance with reaction temperatures
Good PC2. train the line staff effectively to perform 5 2 3
Manufacturing quality checks
Practices (GMP) PC3. plan and manage manpower efficiently to 6 3 3
and Good undertake the needed work/ quality checks, post
Laboratory receiving samples for testing, recording in the
Practices (GLP)) specified documents
PC4. ensure that all work meets applicable QA/QC 10 5 5
guidelines and approved within procedures
PC5. review the data given by analysts and ensure 10 5 5
that it is as per the SOP approved within procedures
PC6. ensure all activities conducted shall meet the 10 5 5
quality standards and norms as specified
PC7. review and update test methods and 6 3 3
procedures according to SOP approved within
procedures as per schedule or when a regulatory
requirement arises according to written procedures
PC8. fill log book, column, reagent, volumetric 6 2 4
solution, working standard, reference standard
entries, calibration records, etc and prepare reports
for document findings and recommendations on
time
PC9. conduct sampling and analysis on time and as 10 5 5
per approved written procedure, along with
reagent, reference standard preparation and
standardisation
PC10. coordinate effectively with personnel in other 4 2 2
disciplines to integrate findings and
recommendations
PC11. analyse root cause of deviations, OOS/OOT 4 2 2
and incidents, take corrective as well preventive
actions to avoid future deviations
PC12. analyse root cause of deviations, OOS/OOT 4 1 3
and take corrective actions
PC13. participate in laboratory investigations and 4 2 2
check the validity/ stability of volumetric
solutions/pH buffers, standards as part of daily
routine and discard expired solutions/standards as
per written procedures
PC14. regular documentation (online/offline) of all 2 1 1
the activities
PC15. conduct regular checks for positioning of all 4 2 2
equipment and instrument tags and undertake
cleaning procedures for instruments post usage
PC16. conduct regular checks on equipment and 4 2 2
instrument conditions, document calibrations and

Quality Control Chemist 13

 Marks Allocation
Total Out Of Theory Skills
Marks Practical
(300)
coordinate with maintenance team for preventive
maintenance
PC17. precision in instrument calibrations as per 4 2 2
specified and approved schedule to minimize
source of errors
PC18. maintain instrument maintenance logs and 2 1 1
follow preventive maintenance schedules
PC19. investigate out of calibration if any, and 2 1 1
impact of previously analysed products as per
approved written procedures
Total 100 47 53
PC1. observe and comply with the company’s 100 10 5 5
current health, safety and security policies and
procedures
PC2. while carrying out work, use appropriate safety 10 5 5
gears like head gear, masks, gloves and other
LFS/N0101 accessories as mentioned in the guidelines
(Maintain a PC3. report any identified breaches in health, safety, 10 5 5
healthy, safe and and security policies and procedures to the
secure working designated person
environment in the PC4. responsible for maintaining discipline at the 10 5 5
life sciences shop-floor/ production area
facility) PC5. identify and correct any hazards that the 10 5 5
individual can deal with safely, competently and
within the limits of their authority
PC6. adhere and comply to storage and handling 10 5 5
guidelines for hazardous material
PC7. identify and recommend opportunities for 10 5 5
improving health, safety, and security to the
designated person
PC8. complete any health, safety and security 10 4 6
activities like safety drills and prepare records
legibly and accurately
PC9. report any hazards that the individual is not 10 4 6
competent to deal with to the relevant person in
line with organizational procedures and warn other
people who may be affected
PC10. follow the company’s emergency 10 5 5
procedures promptly, calmly, and efficiently
Total 100 48 52
LFS/N0302 PC1. receive work instructions from reporting 100 10 5 5
(Coordinate with supervisor
Supervisors and PC2. communicate to reporting supervisor about 10 5 5
colleagues within process-flow improvements, production defects
and outside the received from previous process, repairs and
department) maintenance of equipment as required
PC3. communicate deviations in the production 10 5 5
process to reporting supervisor
PC4. communicate any potential hazards or 10 4 6

Quality Control Chemist 14

 Marks Allocation
Total Out Of Theory Skills
Marks Practical
(300)
expected process disruptions
PC5. handover completed work to supervisor 10 5 5
PC6. work as a team with colleagues and share work 8 4 4
as per their or own work load and skills
PC7. work and support colleagues of other 8 3 5
departments
PC8. train line or reporting staff if needed 10 5 5
PC9. communicate and discuss work flow related 8 4 4
difficulties in order to find solutions with mutual
agreement
PC10. explain what information means and how it 8 4 4
can be used to team members
PC11. document all the control steps undertaken or 8 4 4
recommended to be followed as per the standards
Total 100 48 52
PC1. ensure that total range of checks are regularly 100 16 8 8
LFS/N0320 and consistently performed
(To carry out PC2.use appropriate measuring instruments, 13 5 8
quality checks in equipment, tools, accessories etc. ,as required
the quality control PC3.ensure the status and accuracy of instruments 10 5 5
process) used for measurement
PC4.identify non-conformities to quality assurance 13 5 8
standards
PC5.identify potential causes of non-conformities to 13 5 8
quality assurance standards
PC6.identify impact on final product due to non- 16 8 8
conformance to company standards
PC7.evaluating the need for action to ensure that 6 3 3
problems do not recur
PC8.suggest corrective action to address problem 7 3 4
PC9.review effectiveness of corrective action 6 3 3
Total 100 45 55
LFS/N0314 PC1.report defects/problem/incidents/quality 100 10 5 5
(To carry out issues/test results as applicable in a timely manner
reporting and PC2.report to the appropriate authority as laid 3 1 2
documentation to down by the company
meet quality PC3.follow reporting procedures as prescribed by 4 2 2
standards) the company
PC4.work with production management and 4 2 2
Quality Assurance to provide feedback regarding
quality standards and issues
PC5.help other R&D lab staff with any other testing 4 2 2
required during the developmental work
PC6.identify documentation to be completed 7 3 4
relating to one’s role
PC7.record details accurately in appropriate format 6 3 3
PC8.accurately document the results of the 8 4 4
inspections and testing
PC9.maintain all controlled document files and test 10 5 5

Quality Control Chemist 15

 Marks Allocation
Total Out Of Theory Skills
Marks Practical
(300)
records in a timely and accurate manner
PC10.ensure that the final document meets 7 2 5
regulatory and compliance requirements
PC11.make sure documents are available to all 5 2 3
appropriate authorities to inspect
PC12.evaluate problems and make initial 4 2 2
recommendations for possible corrective action to
supervise
PC13.perform review of records and other 8 4 4
documentation for compliance to established
procedures and Good Documentation Practices
PC14.write and update the inspection procedures, 6 2 4
protocols and checklists
PC15.prepare inspection reports as per the 6 2 4
inspection activity performed
PC16.respond to requests for information in an 4 2 2
appropriate manner whilst following organizational
procedures
PC17.inform the appropriate authority of requests 4 2 2
for information received
Total 100 45 55
LFS/N0103 PC1.inspect the area while taking into account 100 4 2 2
(To ensure various surfaces
cleanliness in the PC2.identify the material requirements for cleaning 5 2 3
work area) the areas inspected, by considering risk, time,
efficiency and type of stain
PC3.ensure that the cleaning equipment is in 5 2 3
proper working condition
PC4.select the suitable alternatives for cleaning the 4 2 2
areas in case the appropriate equipment and
materials are not available and inform the
appropriate person
PC5.plan the sequence for cleaning the area to 4 2 2
avoid re-soiling clean areas and surfaces
PC6.Inform the affected people about the cleaning 4 2 2
activity
PC7.display the appropriate signage for the work 4 2 2
being conducted
PC8.ensure that there is adequate ventilation for 5 2 3
the work being carried out
PC9.wear the personal protective equipment 4 2 2
required for the cleaning method and materials
being used
PC10.use the correct cleaning method for the work 4 2 2
area, type of soiling and surface
PC11.deal with accidental damage, if any, caused 4 2 2
while carrying out the work
PC12.report to the appropriate person any 4 2 2
difficulties in carrying out work

Quality Control Chemist 16

 Marks Allocation
Total Out Of Theory Skills
Marks Practical
(300)
PC13.identify and report to the appropriate person 4 2 2
any additional cleaning required that is outside
one’s responsibility or skill
PC14.ensure that there is no oily substance on the 4 2 2
floor to avoid slippage
PC15.ensure that no scrap material is lying around 4 2 2
PC16.maintain and store housekeeping equipment 4 2 2
and supplies
PC17.follow workplace procedures to deal with any 4 2 2
accidental damage caused during the cleaning
process
PC18.ensure that, on completion of the work, the 4 2 2
area is left clean and dry and meets requirements
PC19.return the equipment, materials and personal 5 2 3
protective equipment that were used to the right
places making sure they are clean, safe and securely
stored
PC20.dispose the waste garnered from the activity 5 2 3
in an appropriate manner
PC21.dispose of used and un-used solutions 5 2 3
according to manufacturer’s instructions, and clean
the equipment thoroughly
PC22.maintain schedules and records for 5 2 3
housekeeping duty
PC23.replenish any necessary supplies or 5 2 3
consumables
Total 100 46 54
Grand Total 600 600 279 321
Percentage 46% 54%
Weightage
Minimum Pass 70%
Percentage to
Qualify

Quality Control Chemist 17

 Life Sciences Sector Skill Council
# 13, 3rd Floor, Palam Marg, Vasant Vihar, New Delhi-110057