Supplier Quality Engineer providing quality engineering support during product launch processes. Collaborating with suppliers and the USA quality engineer to ensure product quality and compliance.
About the role
- Quality Assurance Associate at Lilly providing quality support for drug product manufacturing and batch disposition in pharmaceuticals. Ensuring adherence to quality systems for external manufacturers with a focus on compliance and continuous improvement.
Responsibilities
- 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.
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