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 :

• Participate in the initial evaluation of Contract Manufacturing Organizations (CMOs).
• Should have experience in managing manufacturing operations at External contract manufacturing sites.
• 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 formulation for USA Market.
• Support for the project management team during the execution of exhibit / scale-up batches at the CMO site.
• Collaborate with cross-functional teams including Regulatory Affairs, Manufacturing, and Supply Chain to ensure product quality and compliance.
• 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.