Description

The production machine operator sterile formulations is responsible for operating the machines following Good Manufacturing Practices for the manufacturing / packaging of sterile formulations like Injectable / EyeDrops / Ointment / cosmetics / sanitizers / Irrigating Solutions. The jobholder verifies the output to ensure that in batch manufacturing / continuous manufacturing the quality parameters are met for dosage form manufacturing and performs basic in-process quality checks to ensure safe and quality manufacturing with GMP compliance. He / She also generates the critical records for every activity performed in compliance with data integrity rules.

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

QM-05-LS-00248-2023-V1.1-LSSSDC LFS/Q1301-SI006 5 840 B. Pharma 7th Sem. Or M.Sc. (Chemistry / Analytical Chemistry / Industrial Chemistry) Or Certificate - NSQF Level 4 (Junior Quality Analyst / Wet Lab Analyst Life Sciences) - with minimum 3 Years of experience 12 Months

Theory

Practical

ES

270 480 90

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

Download

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Description

Analyst / Chemist - Quality Control tests samples, reagents from all phases of the manufacturing process to ensure the product quality meets the standards. The individual is responsible for the testing of in-process / input raw materials, packaging materials, product stability of samples, in-process intermediate samples, finished products, preliminary investigation in case of out of specification results, laboratory incidents and handling / preparation of standards. The person is responsible for preparing the documents for reporting the test results and ensures compliance with cGMP, GLP and workplace safety while handling hazardous materials. The role holder also carries out testing of process validation samples and cleaning validation samples.

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

QM-05-LS-00248-2023-V1.1-LSSSDC LFS/Q1301-SI003 5 1050 B. Pharma 7th Sem. Or M.Sc. (Chemistry / Analytical Chemistry / Industrial Chemistry) Or Certificate - NSQF Level 4 (Junior Quality Analyst / Wet Lab Analyst Life Sciences) - with minimum 3 Years of experience 12 Months

Theory

Practical

ES

360 600 90

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

Download

Download

Download

Download

Download

Download

Download

Description

Analyst / Chemist - Quality Control tests samples, reagents from all phases of the manufacturing process to ensure the product quality meets the standards. The individual is responsible for the testing of in-process / input raw materials, packaging materials, product stability of samples, in-process intermediate samples, finished products, preliminary investigation in case of out of specification results, laboratory incidents and handling / preparation of standards. The person is responsible for preparing the documents for reporting the test results and ensures compliance with cGMP, GLP and workplace safety while handling hazardous materials. The role holder also carries out testing of process validation samples and cleaning validation samples.

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

QM-05-LS-00248-2023-V1.1-LSSSDC LFS/Q1301-SI001 5 840 B. Pharma 7th Sem. Or M.Sc. (Chemistry / Analytical Chemistry / Industrial Chemistry) Or Certificate - NSQF Level 4 (Junior Quality Analyst / Wet Lab Analyst Life Sciences) - with minimum 3 Years of experience 12 Months

Theory

Practical

ES

270 480 90

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

Download

Download

Download

Download

Download

Download

Download

Description

Analyst / Chemist - Quality Control tests samples, reagents from all phases of the manufacturing process to ensure the product quality meets the standards. The individual is responsible for the testing of in-process / input raw materials, packaging materials, product stability of samples, in-process intermediate samples, finished products, preliminary investigation in case of out of specification results, laboratory incidents and handling / preparation of standards. The person is responsible for preparing the documents for reporting the test results and ensures compliance with cGMP, GLP and workplace safety while handling hazardous materials. The role holder also carries out testing of process validation samples and cleaning validation samples.

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

QM-05-LS-00248-2023-V1.1-LSSSDC LFS/Q1301-SI007 5 1200 B. Pharma 7th Sem. Or M.Sc. (Chemistry / Analytical Chemistry / Industrial Chemistry) Or Certificate - NSQF Level 4 (Junior Quality Analyst / Wet Lab Analyst Life Sciences) - with minimum 3 Years of experience 12 Months

Theory

Practical

ES

390 720 90

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

Download

Download

Download

Download

Download

Download

Download

Description

Analyst / Chemist - Quality Control tests samples, reagents from all phases of the manufacturing process to ensure the product quality meets the standards. The individual is responsible for the testing of in-process / input raw materials, packaging materials, product stability of samples, in-process intermediate samples, finished products, preliminary investigation in case of out of specification results, laboratory incidents and handling / preparation of standards. The person is responsible for preparing the documents for reporting the test results and ensures compliance with cGMP, GLP and workplace safety while handling hazardous materials. The role holder also carries out testing of process validation samples and cleaning validation samples.

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

QM-05-LS-00248-2023-V1.1-LSSSDC LFS/Q1301-SI002 5 1050 B. Pharma 7th Sem. Or M.Sc. (Chemistry / Analytical Chemistry / Industrial Chemistry) Or Certificate - NSQF Level 4 (Junior Quality Analyst / Wet Lab Analyst Life Sciences) - with minimum 3 Years of experience 12 Months

Theory

Practical

ES

360 600 90

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

Download

Download

Download

Download

Download

Download

Download

Description

Analyst / Chemist - Quality Control tests samples, reagents from all phases of the manufacturing process to ensure the product quality meets the standards. The individual is responsible for the testing of in-process / input raw materials, packaging materials, product stability of samples, in-process intermediate samples, finished products, preliminary investigation in case of out of specification results, laboratory incidents and handling / preparation of standards. The person is responsible for preparing the documents for reporting the test results and ensures compliance with cGMP, GLP and workplace safety while handling hazardous materials. The role holder also carries out testing of process validation samples and cleaning validation samples.

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

QM-05-LS-00248-2023-V1.1-LSSSDC LFS/Q1301-SI005 5 690 B. Pharma 7th Sem. Or M.Sc. (Chemistry / Analytical Chemistry / Industrial Chemistry) Or Certificate - NSQF Level 4 (Junior Quality Analyst / Wet Lab Analyst Life Sciences) - with minimum 3 Years of experience 12 Months

Theory

Practical

ES

360 600 90

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

Download

Download

Download

Download

Download

Download

Download

Description

Analyst / Chemist - Quality Control tests samples, reagents from all phases of the manufacturing process to ensure the product quality meets the standards. The individual is responsible for the testing of in-process / input raw materials, packaging materials, product stability of samples, in-process intermediate samples, finished products, preliminary investigation in case of out of specification results, laboratory incidents and handling / preparation of standards. The person is responsible for preparing the documents for reporting the test results and ensures compliance with cGMP, GLP and workplace safety while handling hazardous materials. The role holder also carries out testing of process validation samples and cleaning validation samples.

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

QM-05-LS-00248-2023-V1.1-LSSSDC LFS/Q1301-SI004 5 900 B. Pharma 7th Sem. Or M.Sc. (Chemistry / Analytical Chemistry / Industrial Chemistry) Or Certificate - NSQF Level 4 (Junior Quality Analyst / Wet Lab Analyst Life Sciences) - with minimum 3 Years of experience 12 Months

Theory

Practical

ES

360 600 90

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

Download

Download

Download

Download

Download

Download

Download

Description

Chemist - In-process Quality Assurance (Pharma, Biologics and Medical Device) performs inprocess quality checks for all the manufacturing products while conducting documentation and verification exercise. The individual is responsible to ensure compliance to systems and procedures, undertakes risk control assessment, and conducts / coordinates in internal/external audit. The role holder also carries out sampling of in-process, finished product.

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

QG-05-LS-00254-2023-V1.1-LSSSDC LFS/Q0302 5 540 B. Pharma (7th Semester) or B. Tech (Biotechnology / Chemical Engineering / Instrumentation & Electronics) 3rd year or M.Sc. (Chemistry / Microbiology / Biotechnology / Life Sciences) 12 Months

Theory

Practical

ES

165 285 90

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

Download

Download

Download

Download

Download

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Description

Microbiologist - Quality Control carries out various microbial analysis of raw materials and finished products in the quality control laboratory as per laid down methods and specifications and performs research work to support the development of new testing protocols. The person is responsible for preparing the documents for reporting the test results and ensures cGMP, GLP and workplace safety. The role holder also carries out the validation of testing protocols and sterilization methods used.

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

QG-05-LS-00264-2023-V1.1-LSSSDC LFS/Q0308 (V3.0) 5 480 B.Sc. (Biochemistry / Biology / Chemistry / Immunology / Biomedical Science / Biotechnology / Microbiology) OR B. Pharma 7th Semester OR B. Tech Biotechnology 3rd year OR M.Sc. (Microbiology) 990(mandatory)

Theory

Practical

ES

150 240 90

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

Download

Download

Download

Download

Download

Download

Download

Description

A Specialist - Quality Assurance (Pharma, Biological Products and Medical Devices) performs physical checks, conducts document verification exercise, ensures compliance to quality management systems and procedures, undertakes risk control assessment, conducts / participates in internal / external audits and also carries out process and equipment validation and in-process sampling, finished product sampling activities.

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

QG-5.5-LS-00998-2023-V1-LSSSDC LFS/Q0313-SI001 5.5 540 M. Pharma final year student OR M. Tech (in relevant field) final year student OR B. Tech (in relevant field) / B. Pharma with 2 Years experience (Quality Assurance / Quality Control / production) OR M.Sc (in relevant subjects) with 2 Years experience (Quality Assurance / Quality Control / production) OR Previous Relevant Qualification of NSQF Level 5 Certificate of Chemist - In-process Quality Assurance (Pharma, Biologics and Medical Device) with 1.5 Years of Exp. in relevant area OR Previous Relevant Qualification of NSQF Level 5 Certificate of Analyst / Chemist - Quality Control with 1.5 Years of Exp. in relevant area OR Previous Relevant Qualification of NSQF Level 5 Certificate of Chemist- Production with 1.5 Years of Exp. in relevant area 990 recommended

Theory

Practical

ES

240 210 90

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

Download

Download

Download

Download

Download

Download

Download

Description

A Specialist - Quality Assurance (Pharma, Biological Products and Medical Devices) performs physical checks, conducts document verification exercise, ensures compliance to quality management systems and procedures, undertakes risk control assessment, conducts / participates in internal / external audits and also carries out process and equipment validation and in-process sampling, finished product sampling activities.

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

QG-5.5-LS-00998-2023-V1-LSSSDC LFS/Q0313-SI008 5.5 540 M. Pharma final year student OR M. Tech (in relevant field) final year student OR B. Tech (in relevant field) / B. Pharma with 2 Years experience (Quality Assurance / Quality Control / production) OR M.Sc (in relevant subjects) with 2 Years experience (Quality Assurance / Quality Control / production) OR Previous Relevant Qualification of NSQF Level 5 Certificate of Chemist - In-process Quality Assurance (Pharma, Biologics and Medical Device) with 1.5 Years of Exp. in relevant area OR Previous Relevant Qualification of NSQF Level 5 Certificate of Analyst / Chemist - Quality Control with 1.5 Years of Exp. in relevant area OR Previous Relevant Qualification of NSQF Level 5 Certificate of Chemist- Production with 1.5 Years of Exp. in relevant area 990 recommended

Theory

Practical

ES

240 210 90

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

Download

Download

Download

Download

Download

Download

Download

Description

A Specialist - Quality Assurance (Pharma, Biological Products and Medical Devices) performs physical checks, conducts document verification exercise, ensures compliance to quality management systems and procedures, undertakes risk control assessment, conducts / participates in internal / external audits and also carries out process and equipment validation and in-process sampling, finished product sampling activities.

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

QG-5.5-LS-00998-2023-V1-LSSSDC LFS/Q0313-SI006 5.5 690 M. Pharma final year student OR M. Tech (in relevant field) final year student OR B. Tech (in relevant field) / B. Pharma with 2 Years experience (Quality Assurance / Quality Control / production) OR M.Sc (in relevant subjects) with 2 Years experience (Quality Assurance / Quality Control / production) OR Previous Relevant Qualification of NSQF Level 5 Certificate of Chemist - In-process Quality Assurance (Pharma, Biologics and Medical Device) with 1.5 Years of Exp. in relevant area OR Previous Relevant Qualification of NSQF Level 5 Certificate of Analyst / Chemist - Quality Control with 1.5 Years of Exp. in relevant area OR Previous Relevant Qualification of NSQF Level 5 Certificate of Chemist- Production with 1.5 Years of Exp. in relevant area 990 recommended

Theory

Practical

ES

300 300 90

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

Download

Download

Download

Download

Download

Download

Download

Description

A Specialist - Quality Assurance (Pharma, Biological Products and Medical Devices) performs physical checks, conducts document verification exercise, ensures compliance to quality management systems and procedures, undertakes risk control assessment, conducts / participates in internal / external audits and also carries out process and equipment validation and in-process sampling, finished product sampling activities.

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

QG-5.5-LS-00998-2023-V1-LSSSDC LFS/Q0313-SI007 5.5 750 M. Pharma final year student OR M. Tech (in relevant field) final year student OR B. Tech (in relevant field) / B. Pharma with 2 Years experience (Quality Assurance / Quality Control / production) OR M.Sc (in relevant subjects) with 2 Years experience (Quality Assurance / Quality Control / production) OR Previous Relevant Qualification of NSQF Level 5 Certificate of Chemist - In-process Quality Assurance (Pharma, Biologics and Medical Device) with 1.5 Years of Exp. in relevant area OR Previous Relevant Qualification of NSQF Level 5 Certificate of Analyst / Chemist - Quality Control with 1.5 Years of Exp. in relevant area OR Previous Relevant Qualification of NSQF Level 5 Certificate of Chemist- Production with 1.5 Years of Exp. in relevant area 990 recommended

Theory

Practical

ES

330 330 90

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

Download

Download

Download

Download

Download

Download

Download

Description

A Specialist - Quality Assurance (Pharma, Biological Products and Medical Devices) performs physical checks, conducts document verification exercise, ensures compliance to quality management systems and procedures, undertakes risk control assessment, conducts / participates in internal / external audits and also carries out process and equipment validation and in-process sampling, finished product sampling activities.

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

QG-5.5-LS-00998-2023-V1-LSSSDC LFS/Q0313-SI008 5.5 600 M. Pharma final year student OR M. Tech (in relevant field) final year student OR B. Tech (in relevant field) / B. Pharma with 2 Years experience (Quality Assurance / Quality Control / production) OR M.Sc (in relevant subjects) with 2 Years experience (Quality Assurance / Quality Control / production) OR Previous Relevant Qualification of NSQF Level 5 Certificate of Chemist - In-process Quality Assurance (Pharma, Biologics and Medical Device) with 1.5 Years of Exp. in relevant area OR Previous Relevant Qualification of NSQF Level 5 Certificate of Analyst / Chemist - Quality Control with 1.5 Years of Exp. in relevant area OR Previous Relevant Qualification of NSQF Level 5 Certificate of Chemist- Production with 1.5 Years of Exp. in relevant area 990 recommended

Theory

Practical

ES

270 240 90

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

Download

Download

Download

Download

Download

Download

Download

Description

A Specialist - Quality Assurance (Pharma, Biological Products and Medical Devices) performs physical checks, conducts document verification exercise, ensures compliance to quality management systems and procedures, undertakes risk control assessment, conducts / participates in internal / external audits and also carries out process and equipment validation and in-process sampling, finished product sampling activities.

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

QG-5.5-LS-00998-2023-V1-LSSSDC LFS/Q0313-SI002 5.5 540 M. Pharma final year student OR M. Tech (in relevant field) final year student OR B. Tech (in relevant field) / B. Pharma with 2 Years experience (Quality Assurance / Quality Control / production) OR M.Sc (in relevant subjects) with 2 Years experience (Quality Assurance / Quality Control / production) OR Previous Relevant Qualification of NSQF Level 5 Certificate of Chemist - In-process Quality Assurance (Pharma, Biologics and Medical Device) with 1.5 Years of Exp. in relevant area OR Previous Relevant Qualification of NSQF Level 5 Certificate of Analyst / Chemist - Quality Control with 1.5 Years of Exp. in relevant area OR Previous Relevant Qualification of NSQF Level 5 Certificate of Chemist- Production with 1.5 Years of Exp. in relevant area 990 recommended

Theory

Practical

ES

240 210 90

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

Download

Download

Download

Download

Download

Download

Download

Description

A Specialist - Quality Assurance (Pharma, Biological Products and Medical Devices) performs physical checks, conducts document verification exercise, ensures compliance to quality management systems and procedures, undertakes risk control assessment, conducts / participates in internal / external audits and also carries out process and equipment validation and in-process sampling, finished product sampling activities.

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

QG-5.5-LS-00998-2023-V1-LSSSDC LFS/Q0313-SI004 5.5 540 M. Pharma final year student OR M. Tech (in relevant field) final year student OR B. Tech (in relevant field) / B. Pharma with 2 Years experience (Quality Assurance / Quality Control / production) OR M.Sc (in relevant subjects) with 2 Years experience (Quality Assurance / Quality Control / production) OR Previous Relevant Qualification of NSQF Level 5 Certificate of Chemist - In-process Quality Assurance (Pharma, Biologics and Medical Device) with 1.5 Years of Exp. in relevant area OR Previous Relevant Qualification of NSQF Level 5 Certificate of Analyst / Chemist - Quality Control with 1.5 Years of Exp. in relevant area OR Previous Relevant Qualification of NSQF Level 5 Certificate of Chemist- Production with 1.5 Years of Exp. in relevant area 990 recommended

Theory

Practical

ES

240 210 90

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

Download

Download

Download

Download

Download

Download

Download

Description

A Specialist - Quality Assurance (Pharma, Biological Products and Medical Devices) performs physical checks, conducts document verification exercise, ensures compliance to quality management systems and procedures, undertakes risk control assessment, conducts / participates in internal / external audits and also carries out process and equipment validation and in-process sampling, finished product sampling activities.

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

QG-5.5-LS-00998-2023-V1-LSSSDC LFS/Q0313-SI005 5.5 540 M. Pharma final year student OR M. Tech (in relevant field) final year student OR B. Tech (in relevant field) / B. Pharma with 2 Years experience (Quality Assurance / Quality Control / production) OR M.Sc (in relevant subjects) with 2 Years experience (Quality Assurance / Quality Control / production) OR Previous Relevant Qualification of NSQF Level 5 Certificate of Chemist - In-process Quality Assurance (Pharma, Biologics and Medical Device) with 1.5 Years of Exp. in relevant area OR Previous Relevant Qualification of NSQF Level 5 Certificate of Analyst / Chemist - Quality Control with 1.5 Years of Exp. in relevant area OR Previous Relevant Qualification of NSQF Level 5 Certificate of Chemist- Production with 1.5 Years of Exp. in relevant area 990 recommended

Theory

Practical

ES

240 210 90

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

Download

Download

Download

Download

Download

Download

Download