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.
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
Requirements
- 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
Benefits
We provide an opportunity to be part of an international company that boasts exceptional technology and a determined team. You can expect a vibrant and adaptable work environment that supports the growth of your personal and professional skills.
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