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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