Model Curriculum. Quality Assurance Chemist. Quality Assurance Chemist SECTOR: SUB-SECTOR:

Transcription

1 Model Curriculum Quity Assurace Chemist Quity Assurace Chemist SECTOR: SUB-SECTOR: OCCUPATION: REFERENCE ID: NSQF LEVEL: LIFE SCIENCES CONTRACT RESEARCH, PHARMACEUTICAL, BIOPHARMACEUTICAL QUALITY LFS/Q0302 Ver10 LEVEL 5

2 Model Curriculum for Quity Assurace Chemist Table of Cotet: Curriculum 3 Aexure1: Assessmet Criteria 15 Aexure2: Traier Prerequisites 18 Page 2 of 19

3 Model Curriculum for Quity Assurace Chemist Quity Assurace Chemist CURRICULUM / SYLLABUS This program is aimed at traiig cadidates for the job of a Quity Assurace Chemist, i the Life Scieces Sector/Idustry ad aims at buildig the followig key competecies amogst the learer Program Name Quity Assurace Chemist Quificatio Pack Name & Quity Assurace Chemist LFS/Q0302 Ver10 Referece ID ID Versio 10 Versio Update Date Pre-requisites to Traiig Traiig Outcomes B Pharma (Preferable)/ B Tech i Biotechology (Preferable for Bio Pharmaceutic)/ B Sc i Microbiology (Preferable for Bio Pharmaceutic)/ BSc i chemistry After completig this programme, participats will be able to: Gai Kowledge about Life Scieces Idustry, Leg ad Regulatory framework ad Pharmacopeia to eable him/herself for establishig the Idustry Stadards i his/her performace Gai scietific kowledge ad skills about Maufacturig ad packig operatios of Pharmaceutic Products, Aytic awareess, Hadlig of complaits, product returs ad recls, vedor maagemet, egieerig ability skills Lear Procedur Kowledge, Quity skills for Sample maagemet system ad Sample Hadlig ad Skills to perform Quity Checks (Ispectio/ Audits), to eable him/herself able to perform iter quity audits i maufacturig, egieerig, QC ad other cross fuctios to esure compliace with GDP, GMP & GLP ad orgaizatio SOP Gai Kowledge of basic statistics ad hads o Kowledge of various statistic tools ad techiques to perform statistic aysis of Maufacturig, packig, QC, egieerig ad product distributio cotrols i maufacturig operatio while esurig compliace with GDP, GMP & GLP ad orgaizatio SOP Verify ad approve l maufacturig ad aytic Equipmet ad Istrumets to eable him/herself while esurig compliace with GMP & GLP Follow ad verify the orms of Good Documetatio e, olie documetatio system, various SOP s ad reportig formats, GMP/ GLP guidelies relatig to the required iformatio capturig, reportig ad documetatio to meet the quity stadards Gai Kowledge of CQA, CPP, QMS for Quity Cotrol, orms for glob stadards like cgmp, ISO, GLP, GDP Capable to verify a Laboratory Iformatio Maagemet System (LIMS) Coduct quity assurace audits ad geerate the reports for audit ad close the audit queries Maitai a hethy, safe ad secure workig eviromet at the pharmaceutic maufacturig shop floor, Laboratory ad area aroud as per EHS requiremet ad Idustri practices ad ability to esure routie maiteace ad cleiess at work area Maage emergecy procedures Page 3 of 19

4 Model Curriculum for Quity Assurace Chemist Coordiate ad support with Supervisor, cross fuctio teams ad withi the team for various fuctio activities e Professio Skills at work like Commuicatio skills (read, write, liste ad speak), Decisio Makig, Plaig & Orgaizig, Customer Cetricity, Problem Solvig, Objectio Hadlig, Aytic Thikig, ad Critic Thikig This course ecompasses Three (3) out of Three (3) Natio Occupatio Stadards (NOS) of Quity Assurace Chemist LFS/Q0302 Ver10 Quificatio Pack issued by Life Scieces Sector Skill Developmet Coucil Sr 1 Orietatio 2 Overview of Productio Process & Packagig operatio for Key Learig Outcomes 10:00 00:00 Uderstad Brief outlie of Life Scieces Idustry, its subsectors Kow about Regulatory Authorities ad Govermet Policies, rules ad Regulatios ad their impact o maufacturig i Life Scieces Idustry Uderstad the Stadards for Maufacturig i Life Scieces like cgmp, ISO, GLP, GDP etc Orietatio of Pharmacopeia Kow about the Existig Orgaizatio i Life Scieces Idustry (i cotext of Large/Medium/ Sml Eterprises): Their Orgaizatio Structure ad Beefits Orietatio o typic maufacturig fuctio i a Life Scieces orgaizatio Kow ad Perform the Role of a Quity Assurace Chemist ad required skills ad kowledge (As per Quificatio Pack) ad its Career Path 10:00 06:00 Lear ad Apply the Fudamet Sciece i API ad Formulatio Productio, packagig icludig review skills i PAS/X activities, Correspodi g NOS LFS/N0303, LFS/N0101, LFS/ N0104 LFS/N0303 Equipmet Required Participat Mau, Power poit presetatio, Case Studies, Computer system, LCD Projector & Scree/ LCD Moitor, Mike, Soud System, Laser Poiter, White/ Black Board, White Board Marker/ chk, duster, flip charts Compressio Machie prototype, Coatig Machie Prototype, FBE Prototype, Hardess Tester, DT Page 4 of 19

5 Model Curriculum for Quity Assurace Chemist Sr Life Scieces Idustry Key Learig Outcomes potecy cculatio for active materis, procedures ad iitiate the chages where ever applicable Coordiatio for self-ispectio audit Addressig of icidets, ivestigatios, CAPA follow-up ad closure Review ad approv of Operatio specificatio, UAT, Master batch records, executed batch report ad executed dispesig report i PAS/X Role of API i typic Pharmaceutic Maufacturig ad role of API particle size i formulatios, Kowledge o Critic Quity Attributes (CQA), Critic Process Parameters (CPP) ad Critic Process Cotrols(CPC) Kow ad apply the Basics of Formulatios icludig Route of Drug Admiistratio ad Various Dosage Forms like Or Solid Dosage, Liquid Or Dosage, Sterile Dosage, Dermatologic Dosage ad their relevat beefits, lie clearace of various maufacturig ad packig operatios, routie samplig of i-process ad its checks, vidatio ad fiished product samples Collectio of stability ad cotrol samples durig packig operatios Kow pack stock checks, batch documets, cotrol o OSD, review ad tredig of Au Product Quity Reviews Correspodi g NOS Equipmet Required Apparatus, Multimill, SA9 Capsule Fillig Prototype, Airjet Cleaig Machie, Filter Press, Ilie homogeiser Cum Mixer, Automatic Fillig Machie, Plaetary mixer(jackatted with electric heatig facility), Preparatio vessel, reactor (t required) & Storage Tak, Agitator- Stirrer, Colloid Mill, Vacuum Homogeizer Mixer, Skid CIP-WIP System, Weighig bace (12kg, 60kg with priter), Rapid mixer graulator (table top 1/5 L capacity), Double coe bleder (5L Capacity), Remi stirrers, Semi- Automatic Cap Seig Machie, O Lie Ispectio, Tur Table, Labellig machie, Iductio machie, Dose moo fillig machie Prototype, Iductio Seig Machie Prototype, Cap Seig Machie Prototype, Semi- Automatic Ropp Cap Seig Machie & Screw Cappig Machie, Glove box isolators for potet drugs, Autoclave, Page 5 of 19

6 Model Curriculum for Quity Assurace Chemist Sr 3 Fudamet s of Aytic to Quity Assurace persoel for Life Scieces Idustry Key Learig Outcomes Gai Kowledge about Quity Maagemet System for Productio i Life Scieces Idustry icludig its itroductio ad importace, QC ad QA Systems, Detail aspects of cgmp, GLP, ISO with referece of quity assurace, O the Job Traiig, materi verificatio, i-process labellig ad status of materi, release, process vidatio ad stability protocols/reports, with drawl of reserve ad stability samples from the productio shop floor Review of SOP, followig safety, heth ad eviromet procedures ad practices 20:00 08:00 Kow ad apply the Basics of Pharmaceutic Sciece ad Chemistry iclusive of Orgaic meclature System, Orgaic Reactio Mechaism, ad Basic Aytic Chemistry fudamets like icludig bacig chemic equatios, chemic equilibria, acid ad base chemistry, stoichiometric cculatios, reductio ad oxidatio chemistry ad iteractio of light with matter Gai ad apply kowledge of compilatio of stability data ad its verificatio, addressig the Quity Correspodi g NOS Equipmet Required Climatic chambers (300 L capacity), Mooblock Rotary Dry Powder Fillig & Seig Machie, Sigle Dose Fillig Machie, Automatic(Liquid) Fillig Machie, Tube Fillig Machies For Lamiated / Plastic Tubes, Multicolum, Rectagular Steriliser, Tube Fillig Machie Prototype, Preparatio vessel, reactor & Storage Tak, Dispo Homogeizer, Ilie Homogeizer, Barcode scaer, Torque tester, Burstig stregth, Pi hole tester, Differeti scaig corimeter LFS/N0303 UV Ayser (Make: Perki elmer/shimadzu/ther mo), FT-IR (Make: Shimadzu/Thermo), Hoge Moisture Ayzer, Seive Shaker & Mesh sizes, Polarimeter, Auto titrator, Meltig poit, Capillary tubes, TLC chamber, Brookfiled Viscometer, Black particle size ayzer, Desity meter, Bulk desity ad Tapped desity tester, Friabilator, Verier cipers, Micrometer screw gauge, Karl Fisher Apparatus Page 6 of 19

7 Model Curriculum for Quity Assurace Chemist Sr Key Learig Outcomes impactig ad oimpactig icidets, deviatios, OOS, OOT, CAPA follow-up ad closure, stability protocol certificatio of commerci ad vidatio batches, esurig the GMP compliace ad cotrol of data itegrity issues i QC, aytic reports, kowledge o SAP, verificatio of stadard operatig procedures/ stadard testig procedures/work sheets/ Aytic report before approv Gai ad apply the kowledge of release process of Certificate of aysis for bled, API & fiished products, vedor specificatios for tredig of Out of Tredig (OOT) results, otificatio closures, Quity maagemet systems, stability master data, pulls & maiteace Kowledge o i-process checks durig maufacturig ad packig operatios Coduct verificatio of materi damage report, review kowledge o Raw materi/i-process/fiished products/ Packig materis/ Stability specificatios before approv, detail aspects like cgmp, GLP, ISO with referece of quity assurace Correspodi g NOS Equipmet Required (Make: Metro, Particle Size Ayzer (Make: Mver Master 2000), Hardess Tester, Laboratory Microscopes(40X ad 100X), HPLC (Make: Agilet/Waters/Shima dzu), Specific optic rotatio Ayser (Make: Rudolph Autopol V/ Jasco 2000 or 3000), Gas chromatographer, Dissolutio Apparatus, DT Apparatus, Aytic bace with priter, Cetrifuge, ph meter with ATC Probe/ Glass electrode, coductivity meter Page 7 of 19

8 Model Curriculum for Quity Assurace Chemist Sr 4 Process Vidatio ad Exhibit stagig for Quity Assurace 5 Documetati o for Quity Assurace Key Learig Outcomes Lear ad apply practic skill for Complex ad - Complex Techiques 06:00 05:00 Gai ad apply the kowledge o hold time data, SHE report availability, compliace i master productio records, vedor status of raw materi prior to start of ew product ad before vidatio batch start, method trasfer, method vidatio ad cibratio reports Review ad approve Master productio records, chage cotrols, bill of materi, performace quificatio protocols ad reports, aytic reports related to exhibit/ submissio batches, regulatory dossiers of various markets Gai ad apply kowledge o R&D developmet strategy, techology trasfer, productio ad maufacturig assurace for executio of process performace quificatio ad verificatio of batches, Quity impactig ad oimpactig icidets, deviatios, OOS, OOT, CAPA follow-up ad closure, detail aspects like cgmp, GLP compliace 34:00 34:00 Cotrol, issue, archive ad distribute records/ reports/ filig, art works, packig stadards, protocols, drug cculatios, upload ad Correspodi g NOS Equipmet Required LFS/N0303 Participat Mau, Power poit presetatio, Case Studies, Computer system, LCD Projector & Scree/ LCD Moitor, Mike, Soud System, Laser Poiter, White/ Black Board, White Board Marker/ chk, duster, flip charts, Sample Vidatio Reports, Sample BMR/BPR, Sample Lab otebook, Sample Productio pla, sample formats of method trasfer, method vidatio ad cibratio reports, GMP ad GLP guidelies, sample labels, LFS/N0303 Participat Mau, Power poit presetatio, Case Studies, Computer system, LCD Projector Page 8 of 19

9 Model Curriculum for Quity Assurace Chemist Sr 6 Egieerig Skills for Quity Assurace Key Learig Outcomes maitai batch documets i database ad SAP, moitor the documets ad their cotrols, cotrol ad issue SOP/STP/ Protocols/work sheets/bmr/bpr ad record of aysis, desig traiig matrix Prepare, compile ad approve au product quity review as per schedule, evuate cotrol charts for API, I-process ad fiished product Coduct icidets, deviatios, OOS, OOT, CAPA follow-up ad closure, detail aspects like cgmp, Good Documetatio e compliace Hadle vedor & market complaits, provide justificatio or clarificatio for customer queries, chage cotrols, iter & exter audits 06:00 06:00 Lear ad apply the cocept ad practic skills for egieerig, HVAC, AHU, water systems, compressed air, electricity, ad facility requiremets, documetatio i various process like reportig defects/problem/icidets/q uity issues/test results Follow the detailed cocepts ad guidelies of Good Documetatio es ad documetatio requiremet for Good Maufacturig es, Correspodi g NOS Equipmet Required & Scree/ LCD Moitor, Mike, Soud System, Laser Poiter, White/ Black Board, White Board Marker/ chk, duster, flip charts, Sample Vidatio Reports, Sample BMR/BPR, Sample Lab otebook, Sample Productio pla, sample formats of method trasfer, method vidatio ad cibratio reports, GMP ad GLP guidelies, sample labels, sample audit reports, ad sample audit resposes LFS/N0303 Participat Mau, Power poit presetatio, Case Studies, Computer system, LCD Projector & Scree/ LCD Moitor, Mike, Soud System, Laser Poiter, White/ Black Board, White Board Marker/ chk, duster, flip charts, diagrams of Egieerig istrumets, sample cibratio ad chage cotrol records, Page 9 of 19

10 Model Curriculum for Quity Assurace Chemist Sr 7 Esure Cleiess i the work area Key Learig Outcomes buildig maagemet systems, eviromet maagemet systems etc Give a audit justificatio give for wrog etry doe i quificatio documets, respose to productio team ad coduct audits for facility, equipmet ad utilities o periodic basis, uderstadig o actio plas ad stickig to the time lies Rreview ad approve Quificatio protocols ad cibratio schedules of equipmet ad facility, prevetive maiteace procedures, desig quificatio, SOP/URS/Stadard cotrol practices, layouts, cleaig vidatio documets 08:00 04:00 Gai ad apply kowledge of differet Materi, chemics ad equipmet ad their cleaig procedure as per maufacturer s guide Gai ad apply Kowledge about Electroic ad Optic Sesors i laboratory equipmet Follow the methodology for storage area ispectio with methods ad materis required for cleaig variety of surfaces ad equipmet, methods to check the treated surface ad equipmet o completio of cleaig, dispos methods Correspodi g NOS Equipmet Required sample job cards, log books, sample cibratio schedule, sample egieerig layouts LFS/N0303 Various types of cleaig materi, chemics, cleaig equipmet, Hf Face Mask, Full Face Mask, Various Cartridges, Safety Goggles, Safety Shoes, Gum Boots, Chemic Absorbet, Self Cotaied Breathig Apparatus, PVC Apro, Gloves(Nitrile, {Heat, acid, chemic} resistat, washig etc), Lab Coat, Surgic Gloves (i Microbiology), Eye washer with sprikler/ Page 10 of 19

11 Model Curriculum for Quity Assurace Chemist Sr 8 Maitai a hethy, safe ad secure workig eviromet i the pharmaceuti c maufacturi g facility ad laboratory Key Learig Outcomes for waste, used/ uused solutios ad relevat SOP, Procedures for reportig ay uidetified soilig ad Escatio procedures for soils or stais that could ot be removed e Related Core Skills ad Professio Skills at work like; Readig, writig, listeig ad speakig, Critic thikig, problem solvig, decisio makig, customer cetricity, pla ad orgaizig 16:00 10:00 Lear ad apply the Basic Cocepts of Safety icludig Hazards, Accidets, Safety Sigs ad Sigs ad Heriech Pyramid Kow about Water Systems at Plat, Egieerig related tools ad techiques to operate the machie safely Use Materi Data Safety Sheet, follow Process of Safety Aysis Lear ad apply Fire Safety cocepts ad act i case of Fire Emergecy at shop floor Use various PPEs i differet productio operatios ad to do Job Safety Aysis for Various productio machies/ equipmet Lear ad apply the Basic Cocepts ad practic skills for maagig Emergecy Procedures ad how to do first aid Correspodi g NOS LFS/N0101 Equipmet Required Mau bottle eye washer, Co2 type Fire Extiguisher, ABC Type Fire Extiguisher Hf Face Mask, Full Face Mask, Various Cartridges, Safety Goggles, Safety Shoes, Gum Boots, Chemic Absorbet, Self- Cotaied Breathig Apparatus, PVC Apro, Gloves(Nitrile, {Heat, acid, chemic} resistat, washig etc), Lab Coat, Surgic Gloves (i Microbiology), Eye washer with sprikler/ Mau bottle eye washer, Co2 type Fire Extiguisher, ABC Type Fire Extiguisher Page 11 of 19

12 Model Curriculum for Quity Assurace Chemist Sr 9 Coordiate with Supervisor, withi team ad cross fuctio the teams Key Learig Outcomes e Related Core Skills ad Professio Skills at work like: Readig, writig, listeig, speakig, Pla ad orgaize, Critic thikig, problem solvig, decisio makig, customer cetricity 18:00 18:00 Maage Supervisor- Reportee Relatioship icludig idetify Parterig Opportuities at work; orietatio o Geer reportig process, protocol ad escatio policy ad Importace of reports ad commuicatio with Supervisor Iteract with cross fuctio teams while coductig iter audits ad commuicate the audit observatios Use the techiques for Collaboratig with Other Groups ad Divisios Apply the coceptu ad practic skills required by QC Chemist i Audits Kow about Importace of cgmp/ GLP/ GDP/QMS/ SOP/ regulatory requiremets related documetatio Follow the Method to Respod to Audit Queries Face Iter Audit Iteractios Use IT i commuicatio ad coordiatio e Related Core Skills ad Professio Skills at Correspodi g NOS Equipmet Required LFS/N0104 Power poit presetatio, Case Studies, Computer system, LCD Projector & Scree/ LCD Moitor, Mike, Soud System, Laser Poiter, White/ Black Board, White Board Marker/ chk, duster, flip charts, Sample Audit Report ad Sample Resposes Page 12 of 19

13 Model Curriculum for Quity Assurace Chemist Sr 10 Iformatio Techology Skills Key Learig Outcomes work : Readig, writig, listeig, speakig, Aytic thikig, problem solvig, decisio makig, customer cetricity 18:00 18:00 Use Basic Computer Skills (Ms Office, Iteret)+ Typig at Work Hadle differet software s used to operate the QC istrumets Apply the kowledge o 21 CFR Part 11 compliace system ad its requiremets 11 Itership 00:00 191:00 Perform the Quity Checks Maitai a hethy, safe ad secure workig eviromet i the pharmaceutic facility of maufacturig /testig/ aysis / research laboratory Coordiate with Supervisor ad withi team members Tot 146:00 300:00 Uique Equipmet Required: Compressio Machie prototype, Correspodi g NOS LFS/N0303, LFS/N0104 LFS/N0303 LFS/N0101 LFS/N0104 Equipmet Required Participat Mau, Power poit presetatio, Computer Lab, LCD Projector & Scree/ LCD Moitor, Mike, Soud System, Laser Poiter, White/ Black Board, White Board Marker/ chk, duster Itership Moitorig Report Coatig Machie Prototype, FBE Prototype, Hardess Tester, DT Apparatus, Multimill, SA9 Capsule Fillig Prototype, Airjet Cleaig Machie, Filter Press, Ilie homogeiser Cum Mixer, Automatic Fillig Machie, Plaetary mixer(jackatted with electric heatig facility), Preparatio vessel, reactor (t required) & Storage Tak, Agitator- Stirrer, Colloid Mill, Vacuum Homogeizer Mixer, Skid CIP-WIP System, Weighig bace (12kg, 60kg with priter), Rapid mixer graulator (table top 1/5 L capacity), Double coe bleder (5L Capacity), Remi stirrers, Semi-Automatic Cap Seig Machie, O Lie Ispectio, Tur Table, Labellig machie, Iductio machie, Dose moo fillig machie Prototype, Iductio Seig Machie Prototype, Cap Seig Machie Prototype, Semi-Automatic Ropp Cap Seig Machie & Screw Cappig Machie, Glove box isolators for potet drugs, Autoclave, Climatic chambers (300 L capacity), Mooblock Rotary Dry Page 13 of 19

14 Model Curriculum for Quity Assurace Chemist Sr Key Learig Outcomes Correspodi g NOS Equipmet Required Powder Fillig & Seig Machie, Sigle Dose Fillig Machie, Automatic(Liquid) Fillig Machie, Tube Fillig Machies For Lamiated / Plastic Tubes, Multicolum, Rectagular Steriliser, Tube Fillig Machie Prototype, Preparatio vessel, reactor & Storage Tak, Dispo Homogeizer, Ilie Homogeizer, Barcode scaer, Torque tester, Burstig stregth, Pi hole tester, Differeti scaig corimeter, UV Ayser (Make: Perki elmer/shimadzu/thermo), FT-IR (Make: Shimadzu/Thermo), Hoge Moisture Ayzer, Seive Shaker & Mesh sizes, Polarimeter, Auto titrator, Meltig poit, Capillary tubes, TLC chamber, Brookfiled Viscometer, Black particle size ayzer, Desity meter, Bulk desity ad Tapped desity tester, Friabilator, Verier cipers, Micrometer screw gauge, Karl Fisher Apparatus (Make: Metro, Particle Size Ayzer (Make: Mver Master 2000), Hardess Tester, Laboratory Microscopes(40X ad 100X), HPLC (Make: Agilet/Waters/Shimadzu), Specific optic rotatio Ayser (Make: Rudolph Autopol V/ Jasco 2000 or 3000), Gas chromatographer, Dissolutio Apparatus, DT Apparatus, Aytic bace with priter, Cetrifuge, ph meter with ATC Probe/ Glass electrode, coductivity meter, Participat Mau, Power poit presetatio, Case Studies, Computer system, LCD Projector & Scree/ LCD Moitor, Mike, Soud System, Laser Poiter, White/ Black Board, White Board Marker/ chk, duster, flip charts, Computer Lab, Itership Moitorig Report, Sample Vidatio Reports, Sample BMR/BPR, Sample Lab otebook, Sample Productio pla, sample formats of method trasfer, method vidatio ad cibratio reports, GMP ad GLP guidelies, sample labels, sample audit reports, ad sample audit resposes, Diagrams of Egieerig istrumets, sample cibratio ad chage cotrol records, sample job cards, log books, sample cibratio schedule, sample egieerig layouts, Various types of cleaig materi, chemics, cleaig equipmet, Hf Face Mask, Full Face Mask, Various Cartridges, Safety Goggles, Safety Shoes, Gum Boots, Chemic Absorbet, Self-Cotaied Breathig Apparatus, PVC Apro, Gloves(Nitrile, {Heat, acid, chemic} resistat, washig etc), Lab Coat, Surgic Gloves (i Microbiology), Eye washer with sprikler/ Mau bottle eye washer, Co2 type Fire Extiguisher, ABC Type Fire Extiguisher Grad Tot Course : _446 Hours _00 Miutes (This syllabus/ curriculum has bee approved by Life Scieces Sector Skill Developmet Coucil) Page 14 of 19

15 Model Curriculum for Quity Assurace Chemist Aexure1: Assessmet Criteria Assessmet Criteria for Quity Assurace Chemist Job Role Quificatio Pack Sector Skill Coucil Quity Assurace Chemist LFS/ Q 0302 Ver10 Life Scieces Sector Skill Developmet Coucil Sr Guidelies for Assessmet 1 Criteria for assessmet for each Quificatio Pack will be created by the Sector Skill Coucil Each Performace Criteria (PC) will be assiged marks proportio to its importace i NOS SSC will so lay dow proportio of marks for ad Skills for each PC 2 The assessmet for the theory part will be based o kowledge bak of questios created by the SSC 3 Idividu assessmet agecies will create uique questio papers for theory part for each cadidate at each examiatio/traiig cetre (as per assessmet criteria laid out i Quificatio Pack) 4 Idividu assessmet agecies will create uique evuatios for skill practic for every studet at each examiatio/traiig cetre based o the assessmet criteria laid out i quificatio pack 5 To pass the Quificatio Pack, every traiee should score a miimum of 70% aggregate i l NOS ad a miimum of 50% i every NOS 6 I case of successfully passig oly certai umber of NOS's, the traiee is eligible to take subsequet assessmet o the bace NOS's to pass the Quificatio Pack Tot Marks (300) Marks Allocatio Out Of Skills LFS/N0303 (Perform Quity Checks) PC1 formulate ad implemet regulatory policies ad procedures PC2 keep oeself abreast with the curret kowledge of relevat regulatios PC3 trai staff i regulatory policies or procedures PC4 to pla ad participate self-ispectios for various departmets o the site as per predefied schedules ad coordiate with cross fuctio teams PC5 compiles statistic data ad writes arrative reports summarizig quity assurace fidigs, og with review of documets PC6 assist i cotiuous improvemet iitiatives to ehace product quity, Page 15 of 19

16 Model Curriculum for Quity Assurace Chemist LFS/N0101 (Maitai a hethy, safe ad secure workig eviromet i the life scieces facility) compliace, drive efficiecies ad cost effectiveess of Quity Assurace team PC7 carry out samplig activities for quity assurace audit across stages PC8 assess repetitive icideces of OOS ad OOT Prepare ad evuate the tred of OOS ad OOT ivestigatio periodicly PC9 provide documet support to regulatory departmets for compilatio of various regulatory documets, icludig verificatios of i-process quity check documetatio PC10 collaborate with the productio/packagig teams for providig lie clearace PC11 support / assig persoel to support iter ad exter audit activities PC12 provide requisite iformatio, documets, clarificatios to supervisors durig actu audits PC13 check storage ad dispos of samples durig ad after aysis Tot PC1 observe ad comply with the compay s curret heth, safety ad security policies ad procedures PC2 while carryig out work, use appropriate safety gears like head gear, masks, gloves ad other accessories as metioed i the guidelies PC3 report ay idetified breaches i heth, safety, ad security policies ad procedures to the desigated perso PC4 resposible for maitaiig disciplie at the shop-floor/ productio area PC5 idetify ad correct ay hazards that the idividu ca de with safely, competetly ad withi the limits of their authority PC6 adhere ad comply to storage ad hadlig guidelies for hazardous materi PC7 idetify ad recommed opportuities for improvig heth, safety, ad security to the desigated perso PC8 complete ay heth, safety ad security activities like safety drills ad prepare records legibly ad accurately PC9 report ay hazards that the idividu is ot competet to de with to the relevat Page 16 of 19

17 Model Curriculum for Quity Assurace Chemist perso i lie with orgaizatio procedures ad war other people who may be affected PC10 follow the compay s emergecy procedures promptly, cmly, ad efficietly Tot PC1 uderstad the work output requiremets LFS/N0104 PC2 comply with compay policy ad rule (Coordiate PC3 proactively iform supervisor o issues with requirig itervetio Supervisor PC4 deliver quity work o time ad report ad team ay aticipated reasos for delays members) PC5 put team over idividu gos PC6 be able to resolve coflicts PC7 lear how to multi-task relevat activities PC8 Impart traiig to team members/crossfuctio team members Tot Grad Tot Percetage Weightage 48% 52% Miimum Pass Percetage to Quify 70% Page 17 of 19

18 Model Curriculum for Quity Assurace Chemist Aexure2: Traier Prerequisites for Job role: Quity Assurace Chemist mapped to Quificatio Pack: LFS/ Q 0302 Ver10 Sr Area Details 1 Job Descriptio To deliver accredited traiig service, mappig to the curriculum detailed above, i accordace with the Quificatio Pack LFS/Q0302 Ver10 2 Perso Attributes Aptitude for coductig traiig, ad pre/ post work to esure competet, employable cadidates at the ed of the traiig Strog commuicatio skills, iterperso skills, ability to work as part of a team; a passio for quity ad for developig others; well-orgaized ad focused, eager to lear ad keep oeself updated with the latest i the metioed field 3 Miimum Educatio Quificatios B Pharma (Preferable)/ B Tech i Biotechology (Preferable for Bio Pharmaceutic)/ B Sc i Microbiology (Preferable for Bio Pharmaceutic)/ BSc i chemistry 4a Domai Certificatio Certified for Job Role: Quity Assurace Chemist mapped to QP: LFS/Q 0302 Ver10 Miimum accepted score is 80% as per LSSSDC guidelies 4b Platform Certificatio Recommeded that the Traier is certified for the Job Role: Traier, mapped to the Quificatio Pack: SSC/1402 Miimum accepted score is 80% as per LSSSDC guidelies 5 Experiece Preferably Miimum Five (5) years experiece i life scieces (Pharmaceutic/ Biopharmaceutic) Quity occupatio for o-traied ad o-quified tet Or Miimum Two (2) years experiece with Quity Assurace Chemist Level-5 quified Page 18 of 19

19 Life Scieces Sector Skill Developmet Coucil 13, Pam Marg, 3rd Floor, Vasat Vihar, New Delhi, PIN Phoe / 407; E mail: ifo@lsssdci; wwwlsssdci