We are looking for an experienced Quality Assurance skilled with 10–12+ years of experience in pharmaceutical API / bulk drug manufacturing.
Key Responsibilities:
- Ensure compliance with cGMP, pharmaceutical quality systems, and regulatory requirements.
- Review and approve SOPs, BMRs, specifications, protocols, and quality documents.
- Handle Deviations, CAPA, Change Controls, OOS/OOT investigations, and Risk Assessments.
- Support internal audits, vendor audits, customer audits, and regulatory inspections.
- Review validation and qualification documents.
- Coordinate with Production, QC, Warehouse, and other departments to ensure quality compliance.
- Conduct GMP training and support continuous quality improvement initiatives.
Qualification: B.Pharm, M.Pharm, B.Sc./M.Sc. Chemistry or equivalent.