as QA representative in multidisciplinary teams, to oversee the following topics: Deviation, Change Control, CAPA Management Sterility Assurance and Contamination Control Process Validation What is in the role for you: Reviews and approves deviations, investigations, CAPAs and Change Controls Reviews and approves process validation documents including risk assessments Oversees site manufacturing activities (oral and parenteral) concerning sterility assurance Owns the Contamination Control Strategy documents of the site Establishes annual Product Quality Reviews Establishes and approves trend reports Ensures regulatory compliance and continuously improves the allocated quality systems and procedures Participates in audits and inspection within the area of responsibility What do you bring to it: Master’s degree preferrably in Life Sciences or related field with track record in Microbiology and Sterility Assurance Minimum of 5 years relevant experience in a GxP regulated pharmaceutical/biotechnology industry Solid computer skills including MS Office required / SAP, LIMS, Quality Management Systems skills are a plus Analytical thinking and problem-solving attitude Multilingual – at least German and English, written and spoken

We provide an opportunity to be a part of an international company that boasts exceptional technology and a determined team. Join our dedicated and agile QA team if you share our enthusiasm and have a desire to create an impact. You can expect a vibrant and adaptable work environment that supports the growth of your personal and academic skills.

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