Senior Executive-IPQA

Role & responsibilities

1. Perform and monitor In-process Quality Assurance activities during the manufacturing process.

2. Responsible to perform line clearance activities in different stages of manufacturing and Monitoring of cleanroom behavior, aseptic activities.

3. Responsible to verify the In-process samples for quality testing and ensure the test results of products at various stages of manufacturing.

4. Review and verify documentation related to manufacturing processes i.e., BMR, BPR and GMP documents, ensuring accuracy and completeness.

5. Regularly inspect and assess manufacturing operations to ensure compliance with quality standards and procedures.

6. Responsible to Preparation & Review of standard operating procedures.

7. Responsible to ensure cGMP and GDP during document preparation and review.

8. Ensure that all in-process activities align with Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMP).

9. Responsible to review of Plasma inward, sampling procedures, Issuance and Reconciliation.

10. Responsible to Review and compliance of Down stream activities and Filling activities as per established procedures.

11. Responsible to involve in Change controls, Deviations, CAPA and other QMS activities.

12. To get involved in Process validation, cleaning validation and APQR activities.

13. To Involve in Risk assessment procedures with the coordination of SMEs.

14. Responsible to perform additional activities assigned by the superiors/ Head of the department.