Quality Assurance Lead

QA Lead (Quality Assurance Lead)

Location

Baddi Plant, Himachal Pradesh

Experience

12+ years

Qualification

• B.Pharm / M.Pharm / MSc
• Strong exposure to injectable manufacturing

Job Summary

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.
• Strong communication and documentation skills.