Job description
Key Responsibilities
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. Quality Systems Oversight 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. Documentation & Data Integrity 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.
Team Management Lead and mentor QA team (IPQA, documentation, QMS, and validation units). Drive training programs for quality awareness, cGMP, and regulatory updates. Product Release Final review and approval of batch manufacturing and analytical records for product release. Coordinate with QC and production for timely batch disposition.
Continual Improvement Drive site-level quality improvement initiatives. Collaborate with cross-functional teams for process optimization and quality enhancement.