Job Title: QA Specialist - Qualification & Validation
As a QA Specialist in Qualification & Validation, you will play a pivotal role in ensuring compliant and robust Commissioning, Qualification, and Validation (CQV) and Cleaning Validation activities across our site. By working closely with cross-functional teams, you will help uphold high-quality standards and ensure that regulatory requirements are consistently met.
Your Responsibilities
- 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 a Subject Matter Expert (SME) for EU GMP requirements, including EudraLex Volume 4, Annex 15, providing guidance to relevant stakeholders.
- Drive quality, compliance, and continuous improvement, including support for changes and corrective actions related to CSV and Cleaning Validation, sharing expertise across teams.
About You
- A 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.
- A keen 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.
Why Join Us
We provide an opportunity to be part of an international company that boasts exceptional technology and a dedicated team. If you share our enthusiasm and have a desire to create an impact, consider joining us! You can expect a vibrant and adaptable work environment that supports the growth of your personal and professional skills.
Ready to Apply?
If this sounds like the next step in your career, we would love to hear from you. Apply online using the form below. Please note that only applications matching the job profile will be considered.
About Bavarian Nordic
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.
Work locationThörishaus, Switzerland