A Quality Control Biologist is responsible for conducting qualitative and quantitative analysis to ensure specified quality of the manufactured bio pharmaceutical products
Brief Job Description: A Quality Control Biologist prepares and tests samples from all phases of the bio pharmaceutical product manufacturing process to ensure that the product quality meets standards. He/she prepares documents that report test results and is responsible for preserving workplace safety while handling hazardous materials. Also responsible for testing in-process/input raw material, packaging materials, in-process samples, finished products, process validation samples, product stability samples and cleaning validation samples, as well as vaccine-candidate test method development, optimization, verification and validation.
Personal Attributes: The individual should have good lab-work skills and thorough understanding of testing material, equipment and processes along with good knowledge of assays.
| Qualifications Pack Code | LFS/Q2301 | ||
|---|---|---|---|
| Job Role | Quality Control Biologist | ||
| Credits(NSQF) | TBD | Version number | 1.0 |
| Industry | Life Sciences | Drafted on | 22/12/14 |
| Sub-sector | Bio Pharmaceutical | Last reviewed on | 01/08/16 |
| Occupation | Manufacturing | Next review date | 01/08/19 |
| NSQC Clearance on | 20/07/2015 | ||
| Job Role | Quality Control Biologist |
|---|---|
| Role Description | Responsible for conducting qualitative and quantitative analysis to ensure specified quality of the manufactured products |
| NSQF level | 5 |
| Minimum Educational Qualifications | B. Pharma / Graduation in Biotechnology/ B. Sc with Chemistry/ Biology/Microbiology/ Biochemistry as major subject (Preferable) |
| Maximum Educational Qualifications | M. Pharma/ M.Tech Chemical/Biotechnology/ M. Sc with Chemistry/ Biology/Microbiology/ Biochemistry as major subject (Preferable) Quality related certification |
| Training(Suggested but not mandatory) | On the job training |
| Minimum Job Entry Age | 20 Years |
| Experience | 0-2 years |
| Performance Criteria | As described in the relevant NOS units |