Specialist QA Compliance and Sterility Assurance 80

vor 2 Wochen

Köniz, Schweiz Bavarian Nordic Berna GmbH Vollzeit

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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