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Specialist Qa Compliance And Sterility Assurance 80 - 100% (f/m/d), Köniz

Letztes Update 2024-06-11
Läuft ab 2024-06-10
ID #2140065142
80 CHF
Specialist Qa Compliance And Sterility Assurance 80 - 100% (f/m/d), Köniz
Switzerland, Bern, Köniz,
Geändert May 2, 2024

Beschreibung

For us, it is all about improving and saving lives
We are a fully integrated vaccine company focused on the development, manufacturing, and commercialization of vaccines, and our vision is to become one of the largest pure-play vaccine companies in the world. At Bavarian Nordic, you will be part of a global team of +1600 dedicated colleagues worldwide, all passionate about making a difference. We offer an inclusive and flexible workplace with a strong focus on personal and professional development, and we welcome people who are passionate about saving lives. If you are open-minded and have the willpower to succeed, we might just be a perfect fit.
At Bavarian Nordic Berna, the Swiss affiliate there are - beside manufacturing activities – professionals in Quality Assurance, Quality Control, Supply Chain and Regulatory affairs working. On the Swiss site of Bavarian Nordic in Thörishaus / Bern there are approx. 160 dedicated and committed professionals working locally and globally.
To complement and strengthen our Quality Assurance Team we are looking for a
Specialist QA Compliance and Sterility Assurance 80 - 100% (f/m/d)
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 Gx P 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.
Founded in 1994, we have more than 25 years of experience in developing life-saving vaccines. We are a global leader in smallpox and mpox vaccines. Our commercial product portfolio contains market-leading vaccines against rabies and tick-borne encephalitis and an Ebola vaccine. We are a global company headquartered in Denmark with a state-of-the-art production facility and sites in Germany, Switzerland, and USA. Our values – our Bavarian Nordic DNA, as we like to call it – are what guide our actions every day. We act as persistent pioneers, embrace change, value being boosted by the team, and believe in protecting lives every day. If that is also a part of your DNA, we invite you to join us in Bavarian Nordic! Bavarian Nordic is an Equal Opportunity Employer.
www.bavarian-nordic.com
Join Bavarian Nordic a fully integrated vaccine company focused on the development, manufacturing and commercialization of life-savings vaccines.

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Jobdetails

Auftragstyp: Vollzeit
Vertragstyp: Dauerhaft
Gehaltsart: Stündlich
Besetzung: Specialist qa compliance and sterility assurance 80 - 100% (f/m/d)
Mindest. Gehalt: 30

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