About the role
Regulatory Compliance
- Ensure site compliance with MHRA, EU GMP, WHO, and other international regulatory requirements.
- Lead regulatory inspections (MHRA, USFDA, EU, etc.) and customer audits; ensure timely CAPA implementation.
- Maintain and ensure readiness of quality systems for inspections.
- Manage and continuously improve QMS (Deviation, Change Control, CAPA, OOS/OOT, Market Complaints, Product Recall).
- Ensure timely review and approval of documents like SOPs, protocols, master BMRs/BPRs, and validation documents.
- Conduct periodic Quality Risk Management (QRM) activities and internal audits.
- Ensure data integrity compliance across systems (manual & electronic); drive ALCOA+ principles.
- Monitor and review batch records, laboratory data, and QA documentation for accuracy and completeness.
- Lead and mentor QA team (IPQA, documentation, QMS, and validation units).
- Drive training programs for quality awareness, cGMP, and regulatory updates.
- Final review and approval of batch manufacturing and analytical records for product release.
- Coordinate with QC and production for timely batch disposition.
- Drive site-level quality improvement initiatives.
- Collaborate with cross-functional teams for process optimization and quality enhancement.