QA Specialist Qualification & Validation (f/m/d)

Bavarian Nordic Berna GmbH; Köniz; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

Bavarian Nordic Berna GmbH is seeking a QA Specialist in Qualification & Validation to oversee CQV and Cleaning Validation activities at our Bern site. You will review strategies, plans and reports, ensuring compliance with EU GMP and company standards while coordinating with Engineering, Manufacturing and MSAT teams.

The role emphasizes rigorous documentation, audit support, and proactive quality improvements to sustain robust qualification and validation processes across facilities and systems.

Qualifikationen

• Strong knowledge of CQV and Cleaning Validation and EU GMP requirements.
• Ability to review and approve CQV/CSV documentation and reports.
• Experience supporting audits and inspections in a regulated setting.

Aufgaben

• Provide QA oversight, review and approval for CQV and Cleaning Validation activities across the site.
• Develop, review and approve CQV and Cleaning Validation strategies, plans, and reports for facilities, utilities, equipment and computerized systems.
• Collaborate with Engineering, Manufacturing, MSAT and other quality functions to ensure compliant execution.
• Support audits and inspections related to CQV and Cleaning Validation and ensure robust documentation.
• Act as SME for EU GMP requirements and drive continuous improvement across teams.

Kenntnisse

GMP knowledge

CQV & Cleaning Validation

Regulatory compliance

Cross-functional collaboration

Attention to detail

Ausbildung

University degree in Pharmacy, Life Sciences, Engineering, Chemistry or comparable field

Jobbeschreibung

About the role

As a QA Specialist Qualification & Validation, you will play an important role in ensuring compliant and robust Commissioning-Qualification-Validation and Cleaning Validation activities across our site. Working closely with cross-functional teams, you will help maintain high quality standards and ensure regulatory requirements are consistently met.

Your tasks

• Provide QA oversight, review and approval for CQV and Cleaning Validation activities across the site, ensuring compliance with regulatory and company requirements Develop, review and approve CQV and Cleaning Validation strategies, plans, protocols and reports for new and existing facilities, utilities, equipment and computerized systems Collaborate closely with Engineering, Manufacturing, MSAT and other quality functions to ensure compliant and timely execution of qualification and validation activities Support audits and inspections related to CQV and Cleaning Validation, ensuring inspection readiness and robust documentation Act as Subject Matter Expert (SME) for EU GMP requirements, including EudraLex Volume 4, Annex 15, and provide guidance to relevant stakeholders Drive quality, compliance and continuous improvement, including supporting changes and corrective actions related to CSV and Cleaning Validation and sharing expertise across teams

About you

• University degree in Pharmacy, Life Sciences, Engineering, Chemistry or a comparable scientific/technical field
• Relevant professional experience in Quality Assurance, Qualification and/or Validation within the pharmaceutical or a similarly regulated industry
• Strong knowledge of CQV and Cleaning Validation, as well as applicable GMP requirements, particularly EU GMP / EudraLex Volume 4, Annex 15
• Strong quality mindset and attention to detail, with the ability to identify compliance risks and drive continuous improvement
• Excellent collaboration and communication skills, with experience working effectively across functions such as Engineering, Manufacturing, MSAT and other quality services
• A proactive and adaptable mindset, combined with strong organizational skills and the ability to manage change and drive topics independently

We provide an opportunity to be part of an international company that boasts exceptional technology and a determined team. Join our 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 professional skills. 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.

Bavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines. We are headquartered in Denmark and have manufacturing, research, and sales offices across Europe and North America.

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. For more information, visit www.bavarian-nordic.com

Join Bavarian Nordic a fully integrated vaccine company focused on the development, manufacturing and commercialization of life-savings vaccines 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. All qualified applications will receive consideration for employment and will not be discriminated against on the basis of race, color, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. For more information visit www.bavarian-nordic.com