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.
