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

Ensure Compliant and Robust Commissioning-Qualification-Validation Activities

Play a pivotal role in maintaining high quality standards and ensuring regulatory requirements are consistently met across the site. Working closely with cross-functional teams, you will help drive quality, compliance, and continuous improvement in Commissioning-Qualification-Validation (CQV) and Cleaning Validation.

Your Responsibilities

• Provide QA oversight, review, and approval for CQV and Cleaning Validation activities to ensure 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 and Annex 15, providing guidance to relevant stakeholders.
• Drive quality, compliance, and continuous improvement by supporting changes and corrective actions related to CSV and Cleaning Validation, while 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.

Our Environment

Join an international company that boasts exceptional technology and a determined team. We offer a vibrant and adaptable work environment that supports the growth of your personal and professional skills. As part of a global vaccine company with a mission to improve health and save lives through innovative vaccines, you will be contributing to a leading portfolio of travel vaccines and serving as a preferred supplier of mpox and smallpox vaccines to governments. We are an Equal Opportunity Employer, ensuring that all qualified applications receive consideration for employment without discrimination based on race, color, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.