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

Bavarian Nordic; Köniz; On-site; CHF 90,000 - 130,000; Full time

Job summary

Bavarian Nordic seeks a QA Specialist in Qualification & Validation to ensure compliant Commissioning-Qualification-Validation and Cleaning Validation activities across our site. You will review strategies, plans and reports and collaborate with Engineering, Manufacturing, MSAT and quality teams to drive quality and continuous improvement.

You will act as SME for EU GMP requirements, including EudraLex Volume 4, Annex 15, and support audits and inspections with robust documentation.

Qualifications

• Bachelor-level or higher degree in a scientific/technical field (pharmacy, life sciences, engineering or chemistry).
• Solid understanding of CQV and Cleaning Validation in regulated environments.
• Experience with EU GMP requirements, especially EudraLex Volume 4, Annex 15.

Responsibilities

• Provide QA oversight and approval for CQV and Cleaning Validation activities.
• Develop and review CQV/Cleaning Validation strategies, plans, protocols and reports.
• Collaborate with Engineering, Manufacturing, MSAT and quality to ensure compliant execution of qualification/validation tasks.
• Support audits and inspections and ensure robust documentation.

Skills

GMP compliance

Cross-functional collaboration

Education

University degree (Pharmacy/Life Sciences/Engineering/Chemistry)

Job description

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.

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

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