Job Description

Summary- Perform external vendor audits pertains to API, KSM (Key Starting Material) & Packaging.
- To review & assessing API synthetic Chemistry (ROS) with respect to risk on potential impurities (Formation of Nitrosamines, Mutagenic etc.,).
- Perform service provider audits of Contract Service Provider & contract packaging organizations.
- Perform GMP compliance by executing corporate audits of Endo sites.
- Timely escalation to the management for any risk noticed during audit.
- Ensure implementation of CAPA for the performed audit in timely manner.
- To review and ensure all documentation pertaining to Vendor qualification of suppliers & service provider for all PAR India sites.
- To execute, review and follow-up for completion of technical agreement pertaining to supplier & service provider.
- Approving and maintaining the manufacturer/ supplier in SAP.
- Handle respective QMS documentation within this function.
- To support manufacturing site as API SME during regulatory inspection.1. Vendor Compliance- To perform the Vendor qualification pertaining to suppliers (Specific to API) & service provider for all PAR India sites.- To review & assess API synthetic Chemistry (ROS) with respect to risk on potential impurities etc.,- To execute, review and follow-up for completion of technical agreement pertaining to supplier & service provider.- Performing vendor audits as per the requirement.- Surveilling all the vendors for its regulatory inspection compliance and health of quality compliance.2. Support- To support lead auditor w.r.t vendor qualification, CAPA tracking and QTA tracking.3. Document control- Handling QMS in Trackwise and documentation in Veeva.4. Regulatory compliance- To monitor the implementation of regulatory CAPA in time and in all sites.Education & Experience

• Master in Science (Chemistry) - Preferably in synthetic.
• Hands on experience in API industry.
• Experience in API Synthetic Chemistry review
• Experience in Quality & Manufacturing.
• Minimum experience: 10 to 14 Years

Commitment to Diversity, Equity, and Inclusion:At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each persons unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.

Endo