- Develop, implement, and maintain the Quality Management System (QMS)
- Ensure compliance with GMP, ISO 13485, MDR, and other applicable regulatory requirements.
- Review and approve Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), Batch Packing Records (BPRs), protocols, and quality documentation.
- Review and approve change controls, deviations, investigations, CAPA, and risk assessments.
- Ensure proper document control and record management.
- Conduct internal quality audits and coordinate external regulatory and customer audits.
- Lead validation activities including process validation, cleaning validation, equipment qualification (IQ/OQ/PQ), and computerized system validation where applicable.
- Ensure implementation of Good Documentation Practices (GDP).
- Oversee chemical, microbiological, and physical testing of raw materials, packaging materials, in-process samples, finished products, and stability samples.
- Ensure laboratory equipment is calibrated, qualified, and maintained.
- Review and approve laboratory analytical reports.
- Ensure timely batch testing and release recommendations.
- Monitor Out-of-Specification (OOS), Out-of-Trend (OOT), and laboratory investigations.
- Ensure proper handling of reference standards and laboratory chemicals.
Pay: ₹30,000.00 - ₹40,000.00 per month
Work Location: In person
