Quality Assurance Officer 2

Responsible for DS (MCM and CCM) IPQA activities. Primary Responsibility (Strategic, Operational, People, Financial responsibilities)

Strategic:

1. Maintain data integrity in all activities at site and ensure appropriate and adequate traceability.

2. Preparation, review and implementation of Standard operating procedures, Protocols etc., pertaining to Quality Assurance department, in line with Global GMP compliance regulations and industry practices related to Biopharma industry.

3. To ensure all time readiness for customer and regulatory audits and inspections.

4. To ensure the Quality Compliance of DS manufacturing, DS Warehouse and Engineering area activities.

Operational:

1. Involving in all in process Quality Assurance activities which are executed at shop floor. 2. Monitoring of raw material and product Dispensing, Manufacturing activities in DS Manufacturing.

3. Collection and submission of Cleaning validation, and Process validation and hold time batch samples along with TRF.

4. To ensure the cGMP compliance in the DS Manufacturing, Warehouse and Engineering areas.

5. Review of Master BMRs/BPRs and executed BMRs/BPRs of DS Manufacturing activities.

6. Review and Execution of all Qualification / Validation activities of Equipment/utilities/facility of DS manufacturing areas, Warehouse, and Engineering. Provide support for review and execution of qualification activities at shop-floor.

7. To support cross functional teams in handling Investigations for root cause analysis in related to any reported Deviations, OOS, OOL and OOT.

8. Review of Change controls and support in closure of action items by ensuring compliance to inhouse and regulatory guidance.

9. Responsible for handling of cell banks.

10. Preparation and Review of Quality Risk Assessment Protocols and Reports.

11. Providing line clearance for manufacturing and warehouse (DS).

12. Handling of other responsibilities (As applicable) assigned by Reporting Manager and Head of the Department.