Job Description Summary
1. This job position is responsible to perform audits globally for vendors [Sterile API, Packaging (Sterile / Non-Sterile), Excipients & Sterile Consumables] and service provider as a part of vendor qualification program.
2. Responsible to perform audits of external CMO (Contract Manufacturing Organization) for sterile manufacturing - SVP (Small Volume Parental), LVP (Large Volume Parental), Biologics & combination products globally as per the current guideline requirement.
3. Responsible for ensuring GMP compliance at site by executing corporate audits of Endo Sterile formulations sites as an SME for sterile operation.
Job Description
- Perform external vendor audits pertains to Sterile API, Packaging (sterile and non-sterile), sterile consumables & Excipient.
- Perform external CMO audits for sterile manufacturing - SVP (Small Volume Parental), LVP (Large Volume Parental), Biologics & combination products globally as per the current guideline requirement.
- Perform service provider audits of Contract Service Provider & contract packaging.
- Ensuring GMP compliance at site by executing corporate audits of Endo Sterile formulations 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, consumable & service provider for all PAR India sites particular to sterility assurance.
- 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 sterile SME during regulatory inspection.
Education & Experience:
- Master's in science (Microbiology) / Master in Pharma. Microbiology is preferable.
- Hands on experience in sterile formulation unit (Manufacturing, Quality, Sterility Assurance & Validation).
- Experience in vendor (Sterile and Non-sterile) auditing & supplier qualification
- 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 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.
Top Skills
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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