Officer - Quality Assurance

Job Description

1. GMP, GLP, Data Integrity, Regulatory guidelines (USFDA, MHRA, WHO).
2. Visiting to DS manufacturing and warehouse facility to ensure that activities are being carried out by following GMP requirements, Regulatory requirement and as per approved procedures.
3. To participate in the manufacturing investigation and CAPA finalization activity.
4. Preparation and review the Risk Assessment and Mitigation Plan.
5. Ensure that process and cleaning validation activities are being carried out by following approved protocols.
6. Review of master document like study protocol, BPR, MFR etc.
7. Review of executed Batch Processing Records for Batch Release.
8. Review of Batch Dispatch Record and verification of dispatch activities in warehouse.
9. Overall coordination for the APQR data compilation and APQR preparation activity.
10. Preparation and review of Quality System SOPs & documents.
11. Review of SOPs as per GMP requirements for all departments

Work Experience

1–4 years in IPQA or AQA in a regulated pharmaceutical environment.

Education

Competencies