The QA Lead will be responsible for overall Quality Assurance operations at the manufacturing facility, ensuring compliance with WHO-GMP, cGMP, regulatory guidelines, data integrity, and quality systems for injectable products.
Key Responsibilities
- Manage overall QA functions for sterile injectable plant.
- Ensure compliance with cGMP, WHO-GMP, and regulatory requirements.
- Review and approve BMR/BPR, SOPs, specifications, protocols, and validation documents.
- Handle deviations, CAPA, change controls, OOS, and investigations.
- Monitor data integrity and documentation practices.
- Ensure qualification and validation activities are completed.
- Oversee line clearance and in-process QA activities.
- Support regulatory submissions and audit readiness.
- Train QA team on GMP and compliance practices.
- Coordinate with Production, QC, Engineering, and Warehouse departments.
Required Skills
- Strong knowledge of sterile injectable regulations.
- Leadership and team handling skills.
- Good understanding of QMS and audit management.
- Solid communication and documentation skills.
📌 Quality Assurance Lead (Baddi)
🏢 Maya Biotech
📍 Baddi
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