Role & responsibilities

- Lead and oversee Quality Assurance and Quality Control functions at the site.
- Ensure compliance with GMP, regulatory requirements, and quality standards.
- Drive site-wide Quality Management Systems, CAPA, deviations, change controls, OOS/OOT, investigations and validation.
- Lead and coordinate regulatory inspections, customer audits and compliance activities.
- Ensure continuous USFDA inspection readiness and effectively manage regulatory audits.
- Provide strategic quality leadership and ensure product quality and patient safety.
- Lead, mentor and develop the QA/QC team.
- Collaborate with Manufacturing, Engineering, R&D; and Regulatory Affairs teams to resolve quality and compliance issues.
- Drive continuous improvement and strengthen the site's quality culture.

Preferred candidate profile





- 15+ years of relevant experience in pharmaceutical manufacturing.
- Strong and balanced exposure to both QA and QC functions.
- Candidates from API / Bulk Drugs / Pharma Manufacturing backgrounds are preferred.
- Robust experience in USFDA audits and regulatory inspections.
- Excellent knowledge of GMP and Quality Management Systems.
- Proven experience in team leadership and quality function management.
- M.Sc. / Ph.D. in Chemistry, Pharmaceutical Sciences or a relevant discipline.

Interested candidates can apply on [email protected] or only calls on (phone hidden).

📌 Lead - Quality Control And Quality Assurance (Navi Mumbai)
🏢 Fact Personnel
📍 Navi Mumbai