Associate – QA
Eli Lilly and Company
full-time
Posted on:
Location Type: Office
Location: Fegersheim • France
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About the role
- Act as the primary Lilly quality contact for the following: Provide quality support for existing products / existing External Manufacturers (EM).
- Ensure EMs are following appropriate quality systems as part of routine operations.
- Build and maintain good communications with EMs and awareness of issues/progress.
- Make regular visits to EMs to ensure current awareness of their operations and maintain a strong working relationship.
- Perform Lilly batch dispositions - approve and provide appropriate documentation.
- Investigate and monitor product quality complaints, in conjunction with TSMS.
- Provide guidance to EMs on resolution of technical/quality issues, in conjunction with TSMS.
- Manage implementation of laboratory accreditation for analytical methods.
- Participate in the development of Annual Product Reviews (APRs) and Periodic Quality Evaluations (PQEs).
- Monitor supply of incoming materials and vendor approvals; carry out vendor audits as required.
- Review, revise and maintain Product Specification Data Sheets (PSDSs), material specifications and Quality Agreements (QAs).
Requirements
- Graduate in Chemistry, Pharmacy, or other similar technical background.
- Significant experience in technical and quality functions within a manufacturing plant, ideally in parenteral products (syringes and/or vials).
- Appreciation of cultural diversity.
- Willingness to travel.
Benefits
- Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
quality supportbatch dispositionsproduct quality complaints investigationlaboratory accreditationAnnual Product ReviewsPeriodic Quality Evaluationsvendor auditsProduct Specification Data Sheetsmaterial specificationsQuality Agreements
Soft skills
communicationrelationship buildingproblem resolutioncultural diversity appreciationwillingness to travel
Certifications
degree in Chemistrydegree in Pharmacy