QA Qualification and Validation Specialist
vor 3 Wochen
For us, it is all about improving and saving lives
In Bern, we're not just expanding, we're reaching a major milestone by launching a new production site and introducing innovative ways of working. This is what being a Persistent Pioneer in our BN DNA is all about bringing a pioneering spirit to everything we do. Whether you're an experienced professional, transitioning from academia, or coming from a related industry, you'll have the unique opportunity to influence how we work and grow.
We are looking to strengthen the QA-Department with a
QA Specialist Qualification & Validation (f/m/d)
Summary
As a QA representative in multidisciplinary teams, responsible to give guidance, to oversee and review/approve qualification/validation documents and risk assessments for the following topics:
- Qualification of Equipment, Facilities, Utilities
- Computer System Validation (CSV)
This role
- Supports 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
Your skills and qualifications
- 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
- Ability to work independently
- Multilingual - at least fluent in German and English, written and spoken
Are you ready to join us in our mission?
If this sounds like the next step in your career, we would love to hear from you. Simply click the 'APPLY' button on the right side of the page and you will be redirected to our application form. We are conducting interviews on an ongoing basis and encourage you to apply as soon as possible.
We look forward to receiving your motivated CV, where you briefly explain your motivation for applying for this particular position. A cover letter is optional.
Founded in 1994, we have +30 years of experience developing life-saving vaccines. We are a global leader in smallpox and mpox vaccines. Our commercial product portfolio contains market-leading vaccines against rabies, tick-borne encephalitis, cholera, typhoid, and Ebola. We are headquartered in Denmark and have manufacturing, research, and sales offices across Europe and North America. 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.
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