- Quality Management System (QMS): Establish, maintain, and continuously improve QMS policies to align with evolving local and international regulatory requirements. [1]
- Compliance & Auditing: Conduct internal audits and lead external regulatory inspections (e.g., USFDA, EMA, CDSCO). Oversee vendor and supplier qualifications. [1, 2, 3]
- Process Oversight: Manage critical quality workflows such as Deviations, Out-of-Specification (OOS) investigations, Change Controls, and CAPA (Corrective and Preventive Actions). [1]
- Batch Release: Review master batch records and analytical results to make the final determination for product disposition and market release. [1]
- Validation & Data Integrity: Provide QA oversight for facility, equipment, and process validations, while ensuring strict adherence to Data Integrity (ALCOA+) principles. [1, 2]
- Team Leadership: Manage, train, and develop QA staff, fostering a robust "quality culture" across all departments (Production, QC, R&D). [1, 2, 3]
Pay: ₹70,000.00 - ₹80,000.00 per month
Benefits:
- Flexible schedule
- Paid sick time
- Paid time off
Work Location: In person
