Specialist Quality Assurance Qualification & Validation (f/m/d)

Bavarian Nordic Berna GmbH

Bavarian Nordic Berna GmbH

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Key information

For us, it is all about improving and saving lives

In Bavarian Nordic, we believe in the power of the team. You will be part of a global company of more than 1000 dedicated people with diverse backgrounds located in four sites (Denmark, Germany, Switzerland, and USA). We believe in creating an inclusive and flexible workplace with a strong focus on personal and professional development.

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 is approx. 150 dedicated and committed professionals working locally and globally.

Bavarian Nordic Berna is looking to strengthen the Team with a

Your responsibilities:

Responsible, as QA representative in multidisciplinary teams, to oversee and review/approve qualification/validation documents and risk assessments for the following topics:

Qualification of Equipment, Facilities, Utilities

Computer System Validation (CSV)

In this role the QA Specialist:

  • leads the implementation of the qualification/validation strategy
  • supports the transfer from project into commercial production phase
  • is the QA representative during qualification/validation work
  • ensures that the allocated quality-systems are compliant with regulatory expectations
  • establishes and continuously improves quality procedures within the area of responsibility
  • continuously improves the allocated quality systems
  • supports changes and corrections for the area of responsibility
  • participates in audits and inspection within the area of responsibility

 

What you bring to the table:

  • Master’s degree in Engineering, Biotechnology, or related field.
  • Minimum of 5 years relevant experience in a GxP regulated pharmaceutical/biotechnology industry.
  • Minimum of 3 years validation and qualification experience required
  • Solid computer skills including MS Office required.
  • 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 IT 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. Additionally, we offer an extensive benefits package and a competitive compensation package.

 

Caught your interest?

We look forward to receiving your application directly on our recruiting portal: https://candidate.hr-manager.net/ApplicationInit.aspx?cid=1576&ProjectId=146796&DepartmentId=18964&SkipAdvertisement=true

Bavarian Nordic Berna

Contact

  • Daniel MauronDirector Human Resources
  • Bavarian Nordic Berna GmbH

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