Role & responsibilities :

- Lead and manage the Plant Quality Assurance department.
- Ensure compliance with cGMP, WHO-GMP, Schedule M, and applicable regulatory guidelines.
- Review and approve Batch Manufacturing Records (BMR), Batch Packing Records (BPR), SOPs, protocols, reports, and quality documentation.
- Handle deviations, CAPA, change controls, OOS, OOT, and risk assessments.
- Ensure effective implementation and maintenance of the Quality Management System (QMS).
- Coordinate internal audits, self-inspections, vendor audits, and regulatory inspections.
- Support regulatory audits conducted by national and international authorities.
- Monitor product quality trends and implement continuous improvement initiatives.




- Train and mentor QA personnel to maintain high-quality standards.
- Collaborate with Production, QC, Engineering, Warehouse, and Regulatory Affairs teams to ensure compliance and operational excellence.
- Ensure timely release of finished products in accordance with quality standards.

Preferred candidate profile :

- Robust understanding of pharmaceutical manufacturing processes.
- Ability to work independently and lead cross-functional teams.
- Excellent organizational and interpersonal skills.
- Commitment to quality, compliance, and continuous improvement.

📌 PLANT Quality Assurance Head (Gujarat)
🏢 Ronald Pharmaceuticals
📍 Gujarat