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
Robust knowledge of sterile injectable regulations.
Leadership and team handling skills.
Positive understanding of QMS and audit management.
Strong communication and documentation skills.
📌 Quality Assurance Lead Baddi
🏢 Maya Biotech
📍 Baddi
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