Job Description

Department Details
Role Summary
Primary responsibilities:
1. Ensure & Implementation of Data Integrity Culture in Quality Control Lab.
2. Adherence to cGMP (Current Good Manufacturing Practice), cGLP (Current Good Laboratory Practice) and GDP (Good Documentation Practice).
3. Performing stability related activity.
4. Receipt of in process, DS, reserve samples and stability samples and storage at QC location.
5. Preparation, qualification and life cycle management of cell banks used in bioassays.
6. Planning and review In-Process, finished product and stability sample testing of monoclonal antibodies and biosimilars and reporting the results.
7. Review of analytical reports of In process, finished product, stability, method validation, method transfer and study, Review of usage log books and Observation data sheets.
8. Preparation and review of method validation, method transfer, study protocol, Stability protocols and summary sheet (Compilation Data) and reports.
9. Planning and performing (Testing) of method transfer, method validation and study samples.
10. Verification of laboratory compliances, which include the validity checking of the reagents, standards, system status etc.
11. Reporting and investigation of Incidents, OOS, OOT and Deviation.
12. Supporting Operational Excellence, 5S in Quality control Lab.
13. Calibration of analytical weighing balance, pH meter etc.
14. Various monitoring such as lab and equipment and cleaning of labs activities
Secondary responsibilities (Wherever applicable):
1. Cross functional coordination with all the inter departments for smooth flow of activities.
2. Supporting to other QC functions (QMS, inter sectional activities) when required.
3. Any activity assigned by supervisor/manager apart from the primary responsibilities.
Key Responsibilities
Primary responsibilities:
1. Ensure & Implementation of Data Integrity Culture in Quality Control Lab.
2. Adherence to cGMP (Current Good Manufacturing Practice), cGLP (Current Good Laboratory Practice) and GDP (Good Documentation Practice).
3. Performing stability related activity.
4. Receipt of in process, DS, reserve samples and stability samples and storage at QC location.
5. Preparation, qualification and life cycle management of cell banks used in bioassays.
6. Planning and review In-Process, finished product and stability sample testing of monoclonal antibodies and biosimilars and reporting the results.
7. Review of analytical reports of In process, finished product, stability, method validation, method transfer and study, Review of usage log books and Observation data sheets.
8. Preparation and review of method validation, method transfer, study protocol, Stability protocols and summary sheet (Compilation Data) and reports.
9. Planning and performing (Testing) of method transfer, method validation and study samples.
10. Verification of laboratory compliances, which include the validity checking of the reagents, standards, system status etc.
11. Reporting and investigation of Incidents, OOS, OOT and Deviation.
12. Supporting Operational Excellence, 5S in Quality control Lab.
13. Calibration of analytical weighing balance, pH meter etc.
14. Various monitoring such as lab and equipment and cleaning of labs activities
Secondary responsibilities (Wherever applicable):
1. Cross functional coordination with all the inter departments for smooth flow of activities.
2. Supporting to other QC functions (QMS, inter sectional activities) when required.
3. Any activity assigned by supervisor/manager apart from the primary responsibilities.
Educational Qualifications
Required Education Qualification: Msc
Required Experience: 3 - 8 years