Senior QA/QC Manager - Pharma / Medical Devices

Position: Senior QA/QC Manager

Industry: Pharmaceutical / Medical Devices
Experience Required: 8-12 Years
Location: Sawarsai, Pen, Dist - Raigad.

Key Roles & Responsibilities
- Oversee and ensure implementation of Quality Assurance systems in compliance with ISO 13485, MDR, and other applicable regulatory requirements.
- Monitor and maintain Quality Management System (QMS) documentation, including SOPs, specifications, protocols, validations, and quality records.
- Ensure compliance with regulatory standards applicable to pharmaceutical and medical device manufacturing.
- Review and approve Batch Manufacturing Records (BMR), Batch Packing Records (BPR), and related quality documents.
- Handle regulatory audits, customer audits, ISO audits, and support inspection readiness activities.
- Guide the QA team in deviation handling, CAPA management, change control, risk assessment, and non-conformance investigations.
- Review and approve validation activities including process validation, cleaning validation, equipment qualification,



and method validation.
- Coordinate with Production, QC, and Warehouse departments for quality compliance activities.
- Provide strategic guidance for continuous improvement in quality systems and manufacturing practices.
- Monitor complaint handling, product recalls, market feedback, and investigation processes.
- Support vendor qualification and supplier audit activities.
- Ensure timely closure of audit observations, deviations, and corrective actions.
- Bachelor’s or Master’s degree in Chemistry.
- Minimum 8-12 years of experience in QA/QC within pharmaceutical and/or medical device manufacturing industries.
- Solid knowledge of ISO 13485, CE requirements, and regulatory compliance.
- Good leadership, documentation, and problem-solving skills.
- Retired professionals with relevant experience are encouraged to apply.

Pay: ₹40,000.00 - ₹45,000.00 per month

Work Location: In person

📌 Senior QA/qc Manager (Pen)
🏢 Atlantic Biomedical
📍 Pen