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This function supports areas such as innovation management, application technology, and production in the development and introduction of new products. The Senior QA Expert for Product Projects is the central point of contact for the Product Line MDS, PDS, and ODS at the production site in Darmstadt/Weiterstadt.

Responsibilities

• Creation of GMP specifications for raw materials and finished products, as well as support in the preparation of the technical finished product specification

• Conducting supplier qualifications and, if necessary, qualification of external service providers, as well as creating and tracking quality assurance agreements with contract manufacturers

• Creation and tracking of change control requests and support in process validation

• Review of manufacturing instructions and validation documents during method validation

• Preparation of quality reviews for products, raw materials, media, and equipment

• Handling of deviations, complaints, and CAPA in the context of product introduction

• Audit support and, if necessary, sole audit management in case of representation

Requirements

• Completed scientific degree, preferably in chemistry, pharmacy, or biology; ideally with a doctorate

• Solid knowledge of ISO 13485 for medical devices as well as additional regulations in quality and risk management and pharmacy (e.g., EXCiPACT, IPEC-GMP)

• Leadership experience is an advantage

• Experience in project management as well as knowledge of Lean Quality and quality tools

• Knowledge of production processes and facilities for medical technology or pharmaceutical products under GMP conditions, preferably in the polymer field

• Knowledge of supplier management and auditing experience is advantageous

• Excellent verbal and written communication skills in German and English

• Strong analytical skills, high problem‑solving competence, and strong team orientation

Your Application
 

To ensure that your application is proceeded as quickly as possible and to protect the environment, please apply online via our careers portal. Further information about Evonik as Employer can be found at https://careers.evonik.com. 

Please address your application to the Talent Acquisition Manager, stating your earliest possible starting date and your salary expectations.

Your Talent Acquisition Manager:

Company is