Manager / Sr.Manager CMO

Job Role : Manager / Sr.Manager (CMO)

Location : Mumbai

Job Summary :

To ensure that SUN Pharma Quality and Compliance Standards, and applicable global regulatory authorities’ requirements are met and that allCMOs achieve, maintain and improve the adequate level of compliance, through “Quality Oversight” for USA Markets.

Key responsibilities:

1. Participate in the initial evaluation of Contract Manufacturing Organizations (CMOs).
2. Should have experience in managing manufacturing operations at External contract manufacturing sites.
3. 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.
4. Ensure that the CMO operations are in compliance with global regulatory standards (FDA, EMA, WHO, ICH) and SUN internal quality systems.
5. Review and maintain quality agreements with CMOs to ensure compliance and quality standards.
6. Review the batch records, validation protocols, and analytical reports for sterile injectable formulation for USA Market.
7. Support for the project management team during the execution of exhibit/scale-up batches at the CMO site.
8. Collaborate with cross-functional teams including Regulatory Affairs, Manufacturing, and Supply Chain to ensure product quality and compliance.
9. Drive continuous improvement initiatives and inspection readiness at CMOs

Qualification : M.Sc / B.Pharm / M.Pharm

Experience : Minimum 13 years of pharmaceutical QA experience, with strong exposure to injectable manufacturing operations for Regulated markets.