Job Description Summary
1. Supplier qualification, Supplier/Vendor audit, Corporate internal audit and Service provider qualification.
2. Responsible for vendor qualification and maintaining documents for vendor pertains to API, KSM, PKG, EXP, CTL and CSP.
Job Description
1. To perform the Vendor qualification pertaining to suppliers & service provider for all PAR India sites. Vendors pertaining to sterile manufacturing facility as well.
2. Maintaining overall qualification status and monitoring for its re-evaluation on scheduled period.
3. To execute, review and follow-up for completion of technical agreement pertaining to supplier & service provider.
4. Performing vendor audits as per the requirement.
5.Surveilling all the vendors for its regulatory inspection compliance and health of quality compliance.
6. To support lead auditor w.r.t vendor qualification, CAPA tracking and QTA tracking.
7. Handling QMS in Trackwise and documentation in Master control.
8. To monitor the implementation of regulatory CAPA in time and in all sites.
Education & Experience:
- Minimum Bachelor degree
- Hands on experience in sterile vendor qualification / Analytical in GMP environment
- Experience in QA / RA / Qualification
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 person’s 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.
What We Do
At Endo, our far-reaching vision is simple: to help everyone we serve live their best life. As a specialty pharmaceutical company, we’re motivated by a strong sense of purpose to find better ways to meet unique medical needs.
Our global team of passionate employees understands the importance of their work. We’re dedicated to supporting one another as we connect with communities and foster partnerships that elevate quality-of-life and bring the best treatments forward.
Our uncompromising commitment results in the delivery of life-enhancing therapies. From intelligent product selection to commercialization, we strive to make a meaningful, tangible impact to help everyone live their best life.
Endo has global headquarters in Malvern, Pennsylvania.
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