Quality Assurance & Compliance
- Ensure compliance with GMP, GLP, and regulatory guidelines.
- Monitor manufacturing, packaging, and testing activities for adherence to approved procedures.
- Review and approve Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR).
Documentation & Record Control
- Prepare, review, and maintain SOPs (Standard Operating Procedures).
- Handle document control system — issuance, revision, archival.
- Ensure all quality-related documentation is accurate and up to date.
Deviation & Change Control
- Investigate deviations, OOS (Out of Specification), and incidents.
- Initiate and track CAPA (Corrective and Preventive Actions).
- Manage change control processes and risk assessments.
Validation & Qualification
- Support qualification activities (IQ, OQ, PQ).
- Participate in process validation, cleaning validation, and equipment validation.
Audit & Inspection
- Support internal and external audits (regulatory, customer audits).
- Prepare audit responses and ensure closure of observations.
- Ensure readiness for inspections by regulatory authorities.
Quality Systems
- Monitor quality metrics and trends.
- Maintain product release procedures and ensure timely release.
- Handle complaints, recalls, and quality risk management.