Quality Assurance
2 weeks ago
Job Purpose:
To ensure that all products are manufactured, tested, and released in compliance with company standards, regulatory guidelines, and Good Manufacturing Practices (GMP).
Key Responsibilities:
- Documentation & Compliance:
- Prepare, review, and control SOPs, Batch Manufacturing Records (BMRs), and Batch Packaging Records (BPRs).
- Maintain documentation as per GMP and company policy.
- Ensure all activities are performed according to SOPs and regulatory requirements.
- In-Process Quality Checks:
- Monitor in-process operations and ensure compliance with quality standards.
- Conduct line clearance and verification before production and packaging starts.
- Deviation & Change Control:
- Record, investigate, and close deviations, CAPA (Corrective and Preventive Actions), and change controls.
- Ensure timely reporting and implementation of corrective actions.
- Audits & Inspections:
- Assist in internal, external, and regulatory audits (WHO, GMP, ISO, etc.).
- Prepare documentation and coordinate with concerned departments during inspections.
- Training & Compliance Monitoring:
- Conduct GMP training for production and quality staff.
- Promote awareness of quality and regulatory compliance across departments.
- Product Release:
- Review batch records and ensure all testing and documentation are completed before product release.
- Vendor Qualification:
- Support vendor audits and ensure raw materials and packaging materials meet quality standards.
- Continuous Improvement:
- Identify areas of improvement in quality systems and suggest process optimizations.
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Job Type: Full-time
Work Location: In person
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