Manager - CMO Quality

About the role

To 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” .

What you'll do

• 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
• 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

What you need

• 12–22 yrs of experience
• ISO 9001
• M.Sc or B.Pharm or M.Pharm