QA Specialist Qualification & Validation (f/m/d)
In Bern, we are expanding with a new production site and introducing innovative ways of working. This role offers the opportunity to influence how we work and grow within a pioneering BN DNA.
Responsibilities
* Act as QA representative within multidisciplinary teams, providing guidance on quality assurance and ensuring regulatory compliance
* Oversight, review and approval of qualification and validation documentation and risk assessments for equipment, facilities, utilities and computer system validation (CSV)
* Support the implementation of the qualification/validation and CSV strategy
* Support the transfer from project into commercial production phase
* Ensure compliance of allocated quality systems with regulatory expectations
* Establish and continuously improve quality procedures within the area of responsibility
* Participate in audits and inspections within the area of responsibility
* Support changes and corrections for 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
* Analytical thinking and problem-solving attitude
* Ability to work independently
* Fluent in German and English, both written and spoken
We provide an opportunity to be part of an international company with exceptional technology and a determined team. You can expect a vibrant and adaptable work environment that supports your personal and professional growth.
Are you ready to join us? 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. Headhunters or recruitment agencies are kindly requested not to contact us regarding this position.
Founded in 1994, we have +30 years of experience developing life-saving vaccines. We are a global leader in smallpox and mpox vaccines. Our values – Bavarian Nordic DNA – guide our actions. We act as persistent pioneers, embrace change, value teamwork, and protect lives every day. Bavarian Nordic is an Equal Opportunity Employer. All qualified applications will receive consideration for employment and will not be discriminated against based on race, color, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
www.bavarian-nordic.com
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