- Gurgaon, Haryana, India
- Manager
- 12+ years
Ensure that Sun Pharma Quality and Compliance Standards and applicable global regulatory authorities’ requirements are met and that all CMOs achieve, maintain and improve the adequate level of compliance through Quality Oversight.
Responsibilities
- Participate in the initial evaluation of Contract Manufacturing Organizations (CMOs).
- Lead, oversee, approve & monitor Quality Management System (QMS) elements reported by CMOs, including change control, deviations, incidents, out of Specification (OOS)/out of Trend (OOT) results, and complaint investigations targeting for injectable & OSD products manufactured for emerging markets.
- Ensure that the CMO operations are in compliance with global regulatory standards (FDA, EMA, WHO, ICH) and SUN internal quality systems.
- Review and maintain quality agreements with CMOs to ensure compliance and quality standards.
- Review the batch records, validation protocols, and analytical reports for sterile injectable formulations & OSD Products manufactured for Emerging markets.
Requirements
- M.Sc
- B.Pharm
- M.Pharm