We are looking for an experienced Sr Manager - QA for our API manufacturing unit in VAPI. The ideal candidate should have a minimum of 15 years of experience, with at least 5+ years in a Site QA Head role. This role will be responsible for managing the Quality Assurance functions at the site and leading a team of 25 staff members.
Key Responsibilities:
- Oversee and manage the Quality Assurance function at the site
- Ensure implementation and compliance with GMP and regulatory standards
- Lead and manage CAPA (Corrective and Preventive Actions) processes
- Handle Market Complaints and ensure effective resolutions
- Manage Change Control, Deviation Management, and APQR (Annual Product Quality Review) processes
- Prepare and review Standard Operating Procedures (SOPs)
- Lead and coordinate with internal teams for customer and regulatory audits