Experience: 15+ years in API / Bulk Drug Intermediate Manufacturing
Qualification: B.Pharm / M.Pharm / M.Sc. Chemistry or equivalent
Key Responsibilities
- Establish and maintain a robust Quality Management System (QMS) and ensure GMP compliance.
- Lead and surveillance audits and compliance improvement activities.
- Drive US FDA regulatory readiness, GMP gap assessments and implementation of corrective actions.
- Plan and lead internal audits, customer audits, supplier audits, certification audits and regulatory inspections.
- Manage deviations, CAPA, change control, investigations, validation and document control.
- Ensure data integrity, SOP compliance, batch record review and quality documentation.
- Coordinate supplier qualification, customer audits, quality agreements and regulatory documentation.
- Train employees on GMP, documentation practices and audit readiness.
- Monitor quality KPIs and ensure timely closure of audit observations.
Candidate Requirements
- Proven experience independently managing QA operations and leading audits.
- Solid knowledge of ICH Q7, applicable GMP requirements, ISO 9001 and data integrity.
- Hands-on experience in QMS implementation, regulatory inspection preparation and CAPA management.
- US FDA inspection experience and ISO Lead Auditor certification preferred.