- Ensure compliance with ISO 13485, GMP, and regulatory requirements.
- Review and approve Batch Manufacturing Records (BMR) and batch release documentation.
- Implement and maintain Standard Operating Procedures (SOPs).
- Conduct internal quality audits and ensure closure of audit observations.
- Monitor and drive Corrective and Preventive Actions (CAPA).
- Handle change control processes.
- Manage deviation, non-conformance (NC), and root cause analysis (RCA).
- Ensure proper document control and archival systems are maintained.
- Support external audits (FDA, notified bodies, customers).
- Review completed BMRs for accuracy, completeness, and compliance.
- Approve or reject batches based on BMR review and test results.
Pay: ₹15,000.00 - ₹25,000.00 per month
Benefits:
- Versatile schedule
Work Location: In person
📌 QA Executive (India)
🏢 MRK Healthcare
📍 India
Reply to this offer
Impress this employer describing Your skills and abilities, fill out the form below and leave Your personal touch in the presentation letter.