- QMS Element Management: Responsible for initiating, reviewing, and closing Quality Management System elements, including Deviations, Corrective and Preventive Actions (CAPA), Change Controls, Incidents, and Market Complaints.
- Documentation & Review: Review and approve Batch Manufacturing Records (BMR), Batch Packing Records (BPR), and Quality Control (QC) data for sterile products. Prepare and update SOPs, Protocols, and Reports.
- Audit Readiness & Compliance: Prepare for, and participate in, internal audits and regulatory inspections (FDA, EMA). Ensure the facility meets all sterile area (clean room) requirements.
- Risk Management: Participate in Quality Risk Assessments (QRM) and investigations to identify root causes of, for example, sterile failures or OOS (Out of Specification) results.
- Sterile Area Monitoring: Oversee environmental conditions of cleanrooms and verify compliance with aseptic manufacturing guidelines.
- Training: Train personnel on GMP, QMS elements, and SOP adherence.
- Validation Support: Assist in process validation, equipment qualification, and media fill activities.
Job Types: Full-time, Permanent
Pay: ₹18,000.00 - ₹30,000.00 per month
Benefits:
- Food provided
- Health insurance
- Life insurance
- Paid time off
- Provident Fund
Work Location: In person
