Specialist QA Compliance and Sterility Assurance 80
vor 4 Monaten
Thörishaus, 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.