We are seeking an experienced QC Manager (AMV/PV) to lead Analytical Method Validation and Process Validation activities. The candidate will be responsible for ensuring compliance with regulatory standards and supporting quality control operations for OSD formulations.
Key Responsibilities:
- Perform and manage Analytical Method Validation (AMV) and Process Validation (PV) activities
- Handle method development, validation, verification, and transfer
- Ensure compliance with regulatory guidelines (ICH, WHO-GMP, etc.)
- Manage stability studies and analytical support for validation batches
- Review and approve validation protocols, reports, and documentation
- Coordinate with QA, Production, and R&D teams for validation activities
- Ensure adherence to QMS systems and data integrity practices
- Handle audits and regulatory inspections related to QC validation
Requirements:
- Experience: 8–12 years in QC (AMV/PV)
- Qualification: M.Sc / B.Pharm / M.Pharm (Pharmaceutical Sciences or relevant field)
- Strong knowledge of analytical instruments (HPLC, GC, UV, etc.)
- Hands-on experience in OSD (Oral Solid Dosage) plant preferred
- Good understanding of regulatory requirements and documentation practices
- Strong leadership, communication, and problem-solving skills
Job Types: Full-time, Permanent
Pay: ₹40,000.00 - ₹50,000.00 per month
Benefits:
- Health insurance
- Provident Fund
Work Location: In person
