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Description |
Biologist/Biotechnologist is a critical role and performs the critical activities in various specialized areas like Manufacturing of Bio-products / Biologics Formulation Products or In-Vitro Micro propagation of Plants or Quality Control of Biological Products / Plant based products. Sometimes the role holder is also involved in research work for computational Biology. He/ she is responsible to ensure documentation, quality assurance and compliance with applicable regulation at workplace. The individual also guides junior staff for manufacturing/ quality control of biological products. He/she is involved in relevant processes as per standard operating procedures (SOP) and is responsible for implementation of quality standards like good manufacturing practices, good documentation practices, good storage practices, 5S system etc. | ||||||||
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| QG-05-LS-00372-2023-V1-LSSSDC | LFS/Q4101-SI004 | 5 | I | 5540 | 18 | B.Tech (biotechnology) Final Year Student or M.Sc (biology and biotechnology related subject ) Final Year Student OR B. Pharma final year student (with Pharmacognosy Subject) or B. Sc. (biology and biotechnology related subject ) Pass or NSQF Level 4 Certificate of Production Machine Operator Sterile Formulations with 3 Years of Exp. |
990 Hours | ||
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| 180 | 300 | 60 | |||||||
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Description |
Biologist/Biotechnologist is a critical role and performs the critical activities in various specialized areas like Manufacturing of Bio-products / Biologics Formulation Products or In-Vitro Micro propagation of Plants or Quality Control of Biological Products / Plant based products. Sometimes the role holder is also involved in research work for computational Biology. He/ she is responsible to ensure documentation, quality assurance and compliance with applicable regulation at workplace. The individual also guides junior staff for manufacturing/ quality control of biological products. He/she is involved in relevant processes as per standard operating procedures (SOP) and is responsible for implementation of quality standards like good manufacturing practices, good documentation practices, good storage practices, 5S system etc. | ||||||||
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| QG-05-LS-00372-2023-V1-LSSSDC | LFS/Q4101-SI005 | 5 | I | 540 | 18 | B.Tech (biotechnology) Final Year Student or M.Sc (biology and biotechnology related subject ) Final Year Student OR B. Pharma final year student (with Pharmacognosy Subject) or B. Sc. (biology and biotechnology related subject ) Pass or NSQF Level 4 Certificate of Production Machine Operator Sterile Formulations with 3 Years of Exp. |
990 Hours | ||
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| 180 | 300 | 60 | |||||||
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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. | ||||||||
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| QG-5.5-LS-00264-2024-V2-LSSSDC | LFS/Q0308 | 5.5 | I | 540 | 18 | UG Degree or equivalent (Biochemistry/Biology/ Chemistry/ Immunology /Biomedical Science/Biotechnology/Microbiology) OR M.Sc. (Biochemistry/Biology/Chemistry/ Immunology/ Biomedical Science/ Microbiology) |
990 Hours | ||
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| 175 | 275 | 90 | |||||||
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Description |
Chemist- In-process Quality Assurance (Pharma, Biologics and Medical Device) performs in-process 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. | ||||||||
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| QG-05-LS-03407-2024-V2-LSSSDC | LFS/Q0302 | 5 | I | 510 | 17 | Completed 2nd Year of UG (Pharma/Biotechnology/Chemical Engineering/Instrumentation & Electronics) or M.Sc. (Chemistry/ Microbiology/ Biotechnology/ Life Sciences) |
12 Months | ||
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| 155 | 265 | 90 | |||||||
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Description |
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. | ||||||||
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| QG-05-LS-03406-2024-V2-LSSSDC | LFS/Q1301-SI001 | 5 | I | 690 | 23 | UG Diploma or Equivalent (Biochemistry/Biology/Chemistry/Immunology/Biomedical Science/ Microbiology/ Pharma/ Biotechnology ) Or Diploma in Pharmacy (after 12th) Or M.Sc. (Chemistry/ Analytical Chemistry / Industrial Chemistry) |
12 Months | ||
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| 185 | 5415 | 90 | |||||||
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Description |
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. | ||||||||
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| QG-05-LS-03406-2024-V2-LSSSDC | LFS/Q1301-SI002 | 5 | I | 900 | 30 | UG Diploma or Equivalent (Biochemistry/Biology/Chemistry/Immunology/Biomedical Science/ Microbiology/ Pharma/ Biotechnology ) Or Diploma in Pharmacy (after 12th) Or M.Sc. (Chemistry/ Analytical Chemistry / Industrial Chemistry) |
12 Months | ||
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| 255 | 555 | 90 | |||||||
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Description |
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. | ||||||||
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| QG-05-LS-03406-2024-V2-LSSSDC | LFS/Q1301-SI003 | 5 | I | 900 | 30 | UG Diploma or Equivalent (Biochemistry/Biology/Chemistry/Immunology/Biomedical Science/ Microbiology/ Pharma/ Biotechnology ) Or Diploma in Pharmacy (after 12th) Or M.Sc. (Chemistry/ Analytical Chemistry / Industrial Chemistry) |
12 Months | ||
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| 255 | 555 | 90 | |||||||
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Description |
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. | ||||||||
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| QG-05-LS-03406-2024-V2-LSSSDC | LFS/Q1301-SI004 | 5 | I | 900 | 30 | UG Diploma or Equivalent (Biochemistry/Biology/Chemistry/Immunology/Biomedical Science/ Microbiology/ Pharma/ Biotechnology ) Or Diploma in Pharmacy (after 12th) Or M.Sc. (Chemistry/ Analytical Chemistry / Industrial Chemistry) |
12 Months | ||
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| 255 | 555 | 90 | |||||||
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Description |
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. | ||||||||
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| QG-05-LS-03406-2024-V2-LSSSDC | LFS/Q1301-SI005 | 5 | I | 690 | 23 | UG Diploma or Equivalent (Biochemistry/Biology/Chemistry/Immunology/Biomedical Science/ Microbiology/ Pharma/ Biotechnology ) Or Diploma in Pharmacy (after 12th) Or M.Sc. (Chemistry/ Analytical Chemistry / Industrial Chemistry) |
12 months | ||
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| 240 | 360 | 90 | |||||||
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Description |
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. | ||||||||
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| QG-05-LS-03406-2024-V2-LSSSDC | LFS/Q1301-SI006 | 5 | I | 690 | 23 | UG Diploma or Equivalent (Biochemistry/Biology/Chemistry/Immunology/Biomedical Science/ Microbiology/ Pharma/ Biotechnology ) Or Diploma in Pharmacy (after 12th) Or M.Sc. (Chemistry/ Analytical Chemistry / Industrial Chemistry) |
12 months | ||
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ES |
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| 240 | 360 | 90 | |||||||
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Description |
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. | ||||||||
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| QG-05-LS-03406-2024-V2-LSSSDC | LFS/Q1301-SI007 | 5 | I | 900 | 30 | UG Diploma or Equivalent (Biochemistry/Biology/Chemistry/Immunology/Biomedical Science/ Microbiology/ Pharma/ Biotechnology ) Or Diploma in Pharmacy (after 12th) Or M.Sc. (Chemistry/ Analytical Chemistry / Industrial Chemistry) |
12 months | ||
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| 255 | 555 | 90 | |||||||
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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. | ||||||||
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| QG-5.5-LS-00998-2023-V1-LSSSDC | LFS/Q0313-SI001 | 5.5 | I | 540 | 18 | 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 |
6 months | ||
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Practical |
ES |
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| 240 | 210 | 90 | |||||||
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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. | ||||||||
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| QG-5.5-LS-00998-2023-V1-LSSSDC | LFS/Q0313-SI002 | 5.5 | I | 540 | 18 | 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 |
6 months | ||
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Theory |
Practical |
ES |
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| 240 | 210 | 90 | |||||||
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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. | ||||||||
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| QG-5.5-LS-00998-2023-V1-LSSSDC | LFS/Q0313-SI003 | 5.5 | I | 540 | 18 | 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 |
6 months | ||
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Theory |
Practical |
ES |
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| 240 | 210 | 90 | |||||||
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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. | ||||||||
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| QG-5.5-LS-00998-2023-V1-LSSSDC | LFS/Q0313-SI004 | 5.5 | I | 540 | 18 | 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 |
6 months | ||
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Theory |
Practical |
ES |
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| 240 | 210 | 90 | |||||||
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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. | ||||||||
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| QG-5.5-LS-00998-2023-V1-LSSSDC | LFS/Q0313-SI005 | 5.5 | I | 540 | 18 | 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 |
6 months | ||
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Theory |
Practical |
ES |
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| 240 | 210 | 90 | |||||||
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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. | ||||||||
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| QG-5.5-LS-00998-2023-V1-LSSSDC | LFS/Q0313-SI006 | 5.5 | I | 690 | 23 | 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 |
6 months | ||
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Theory |
Practical |
ES |
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| 300 | 300 | 90 | |||||||
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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. | ||||||||
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| QG-5.5-LS-00998-2023-V1-LSSSDC | LFS/Q0313-SI007 | 5.5 | I | 750 | 25 | 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 |
6 months | ||
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Theory |
Practical |
ES |
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| 330 | 330 | 90 | |||||||
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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. | ||||||||
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| QG-5.5-LS-00998-2023-V1-LSSSDC | LFS/Q0313-SI008 | 5.5 | I | 600 | 20 | 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 |
6 months | ||
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Theory |
Practical |
ES |
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| 270 | 240 | 90 | |||||||
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Description |
This standard is about analyzing samples using a High-Performance Liquid Chromatography (HPLC) system. Learner will be expected to be able to set up the system for the analysis, ensure that the samples are ready for analysis, load and run all samples, obtaining all necessary results. He/She will be expected to initiate and complete tasks and procedures exercising a degree of autonomy and judgement within specified parameters. This person will also be aware of the limits of the authority and the procedures to be followed. | ||||||||
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| NG-5.5-LS-03308-2024-V1-LSSSDC | LFS/N0361 | 5.5 | I | 90 | 3 | Completed 3rd year of 3-year/ 4-years UG in Chemistry/ Microbiology/Marine science/ Biotechnology/ Biochemistry/ Botany/ Zoology / Pharma/ Chemical Engineering/ Food Technology/Veterinary science/ any other relevant science field involving Chemical or Biological analysis Or Pursuing 1st year of 2-year PG program after completing 3- year UG degree in Chemistry/ Microbiology/Marine science/ Biotechnology/ Biochemistry/ Botany/ Zoology/ Food Technology/ Veterinary science/ any other relevant science field involving Chemical or Biological analysis |
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| 24 | 66 | ||||||||