QA CSV Specialist (m/f/d)
Responsibilities
- Act as QA liaison: Represent the QA department and serve as the primary contact for CSV-related matters with internal and external stakeholders
- Ensure compliance: Monitor evolving industry regulations (GMP Annex 11, 21 CFR Part 11, GAMP, PIC/S) and integrate best practices into local policies and procedures
- System validation: Oversee validation and lifecycle management of computerized systems (MES, Delta V, spreadsheets, bench-top equipment)
- Technical guidance: Provide expert IT input to support GMP decisions on system validation and lifecycle management
- Continuous improvement: Develop and implement procedures, Validation Plans, and Master Plans to enhance efficiency and compliance
- Project leadership: Define scope, create implementation plans, track progress, and proactively address risks to keep projects on schedule
- Auditing: Conduct audits to ensure validation activities meet regulatory and corporate standards
- Cross-functional collaboration: Partner with engineering, automation, and operations to assess new applications and define validation requirements
- Escalation support: Act on behalf of the QA CSV Manager to ensure timely resolution of GMP issues
Profile
- Education: Bachelor’s degree in Engineering, Information Technologies, Natural Sciences, or related field
- Experience: in the pharmaceutical industry with advanced expertise in CSV and GMP regulations
- Languages: English required; German is a plus
Benefits
- A dynamic and impactful role in a growing pharmaceutical environment
- Opportunity to shape technical projects that directly support strategic growth
- Collaborative team culture with clear ownership and accountability
About Hays
Our many years of recruitment experience and our expert knowledge of the engineering job market make us a strong partner for engineers and technicians. We maintain close relationships with customers across all industries and therefore can provide engineering specialists with exciting projects and attractive job opportunities, drawing on your personal interests and experience. As your professional companion, we support you throughout the entire process, from the first contact to the first day on your new job – all this completely free of charge. Register now and look forward to many interesting and suitable positions and projects.
Staffing process for freelance specialists
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
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1. Analysis of qualifications
We carry out a detailed analysis of your technical qualifications on the basis of your CV, your application documents and your profile.
Contact at Hays
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