As CSV Lead (m/f/x), you are responsible for managing the IT Validation strategies and provide guidance to other departments and sites in relation to the Computer System Validation.
These tasks are waiting for you:
- Responsible for Quality Management of IT systems implementation projects
- Ensure compliance with regulatory requirements such as 21 CFR Part 11, GMP Annex 11, GAMP5 guidelines
- Development of design requirements for new electronic business solutions in a GxP environment
- Execution and creation of validation and testing strategies
- Oversee the review, enhancement, and implementation of IT quality processes, standards, and systems
- Optimization of the processes and life cycle in relation to the global validation
- Lead and execute internal and external audits, with accountability for managing IT service providers and ensuring supplier compliance
This completes your profile:
- Studies in Life Sciences, Computer Science, Business, or a related field (or equivalent relevant experience preferred)
- Several years of experience in computer system validation
- Familiarity with quality risk management and GxP regulatory frameworks
- Strong knowledge and practical application of FDA and EU regulations and other compliance standards
- Fluent German and English skills
This is what the position offers you:
- Exciting work environment, where you can implement your expertise
- Attractive salary compensation
- Innovative approach
- Flexible working hours
- 30 days of holiday time each year
Information about our client:
A global contract manufacturer specializing in pharmaceuticals, providing comprehensive services from active ingredient production to final drug packaging. It supports pharmaceutical and biotech companies in key therapeutic areas like oncology, cardiology, and rare diseases, with a strong focus on quality and regulatory compliance across its international facilities.
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We are a trusted partner for every step from Discovery through to Development. So, no matter where you are in your journey, we're here to help you make a difference. We are a trusted partner for every step from Discovery through to Development. So, no matter where you are in your journey, we're here to help you make a difference.