Validation Specialist
vor 22 Stunden
B-Hive Switzerland is a leading engineering company that has experienced significant growth since its founding in 2017.
We are currently seeking a talented CSV Expert to join our team and contribute to the development of our activities in Switzerland.
Job Responsibilities:- Define a comprehensive validation strategy and develop a clear approach to validate systems in compliance with relevant regulations.
- Plan validation activities, considering project-specific risks and needs.
- Create key validation documents, including the Validation Master Plan, URS, protocols, and traceability matrices.
- Provide expertise to meet validation requirements.
- Identify and document data compliance-related risks.
The ideal candidate will have an engineering degree and proven experience in computer system validation within the pharmaceutical industry.
Familiarity with OWL, W3C standards, GMP, and 21 CFR Part 11 is essential.
Technical knowledge of tools such as AWS, LIMS, MES, and SAP is also required.
Languages: Professional proficiency in English is necessary.
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