- Manage stability studies, including sample issuance, storage, monitoring, and documentation.
- Handle control sample management as per SOPs and regulatory requirements.
- Prepare, review, and maintain QA documentation, logs, and records.
- Ensure compliance with GMP, GDP, and company quality systems.
- Coordinate with QC and Production for stability and documentation-related activities.
- Support internal audits, regulatory inspections, and quality compliance initiatives.
Requirements:
- B.Pharm/M.Pharm/M.Sc. with 25 years of experience in QA.
- Hands-on experience in stability studies, control sample management, and QA documentation.
- Valuable knowledge of GMP, GDP, and pharmaceutical documentation practices.