Title: Sr. Manager- CMO

6 hours ago

Mumbai, Maharashtra, India sun pharma industries ltd panoli(dist-bharuch) Full time ₹ 12,00,000 - ₹ 36,00,000 per year
Job Description

Title: Sr. Manager- CMO

Date: Apr 25, 2025
Location: Sun House - Corporate Office
Company: Sun Pharmaceutical Industries Ltd
Position: Sr. Manager 2 - CMO
Department: Global Quality CMO
Location: Mumbai/ Baroda
Reporting Manager Title: DGM- CMO

Job Summary:

To ensure that SUN Pharma Quality and Compliance Standards, and applicable global regulatory authorities requirements are met and that all SUN affiliates, CMO, Suppliers and SUN sites / Operational Units to achieve, maintain and improve the adequate level of compliance, through Quality Oversight and Independent auditing and Follow-up.

Essential Job Functions:
  • Participate in the initial evaluation of Contract Manufacturing Organizations (CMOs).
  • Oversee and approve 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.
  • Review and approve master documents from CMOs, such as Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), specifications, validation protocols, and stability protocols.
  • Provide support during regulatory audits at CMO sites related to SUN Pharma product approvals.
  • Engage in critical investigations at CMO sites, including OOS results, deviations, and complaints.
  • Review and maintain quality agreements with CMOs to ensure compliance and quality standards.
  • Initiate QMS documents in the Trackwise system, inform the respective CMO, and track to ensure closure of initiated QMS elements.
  • Monitor and oversee activities carried out at CMO sites to ensure compliance with SUN Pharma standards.
  • Review executed documents from CMOs related to SUN Product to ensure accuracy and compliance.
  • Perform batch release of SUN products manufactured at CMO sites, ensuring they meet quality standards.
  • Conduct regular visits to CMO sites, prepare detailed visit reports, and follow up on any issues identified.
  • To makes sure that, SUN Manufacturing Sites, Contract Manufacturing Organisations, and Affiliate Companies are prepared for Regulatory Agency Inspections e.g. through "Mock" inspections, audits and supports activities whenever required.
  • To participate in the product release sites / Qualified Person sites audits to ensure that the product is being released as per the regulatory requirement.
  • To prepare Monthly report and to highlight the key area of concerns.
  • To participate in the trainings to update on current / upcoming regulations.
  • To follow the Corporate Quality Policies/ Global Quality Standards (GQS) and applicable Regulatory Guidelines.
  • Participate and execute the project work as allotted by reporting authority.
  • To perform the risk assessment.
Requirements and Qualifications:
  • M.Sc./ B. Pharm / M. Pharm or equivalent.
Industrial Experience & Knowledge:
  • Total 15-18 years of experience
  • Experience in CMO and working knowledge with Regulatory markets is preferable.

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