Quality Assurance Officer

5 days ago

Baddi, India Mediwell Biotech Full time

Job Responsibilities:

- Ensure compliance with GMP, GDP, GLP, and regulatory guidelines.
- Prepare, review, and update Standard Operating Procedures (SOPs).
- Maintain and verify Batch Manufacturing Records (BMR) and Batch Packing Records (BPR).
- Manage deviations, CAPA, change controls, and OOS investigations.
- Conduct internal audits and assist in regulatory inspections (USFDA, WHO-GMP, MHRA, etc.).
- Perform supplier and vendor audits to ensure material quality standards.
- Participate in process validation, cleaning validation, and equipment qualification (IQ, OQ, PQ).
- Ensure water, air, and environmental monitoring in production areas.
- Coordinate with the QC department for testing and material release.
- Investigate customer complaints and implement corrective actions.
- Support product recall procedures and compliance with regulatory requirements.
- Conduct GMP and quality training for production and warehouse staff.
- Identify and implement process improvements for quality compliance.
- Ensure proper storage conditions, temperature monitoring, and good distribution practices (GDP).

Work Environment:

- Office-based role with frequent interaction with production, QC, and warehouse teams.
- Requires on-site presence in manufacturing areas for process validation and audits
- Involves regulatory inspections, documentation work, and occasional extended hours during audits or compliance reporting.

**Job Types**: Full-time, Permanent

Pay: ₹13,000.00 - ₹25,000.00 per month

Work Location: In person

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