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 Positive 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: ₹15,000.00 - ₹22,000.00 per month

Work Location: In person

📌 Qc/qa Chemist Pen (Pune)
🏢 Atlantic Biomedical
📍 Pune