Data Compliance Specialist

7 days ago


Waterford, Waterford, Ireland beBeeCSV Full time €75,000 - €102,000

Proclinical is seeking a CSV Engineer to support the validation and compliance of computerized equipment and systems in a sterile pharmaceutical manufacturing environment.

Key Responsibilities
  • Develop and execute validation protocols (DQ, IQ, OQ, PQ) for computerized equipment and control systems.
  • Generate and review validation documentation, including protocols, reports, and revalidation plans.
  • Provide technical expertise on current FDA and EU validation requirements.
  • Participate in the change control process, advising on CSV-related matters.
  • Ensure compliance with cGMP, health, safety, and environmental regulations.
  • Troubleshoot validation issues and provide solutions during project execution.
  • Review and approve site change controls and ensure validation status aligns with regulatory expectations.
Requirements
  • Degree in Science or Engineering.
  • Strong understanding of GAMP, ISPE Baseline Guides, and quality management systems.
  • Hands-on experience in validation activities within a healthcare or pharmaceutical manufacturing environment.
  • Knowledge of cGMP regulations and compliance requirements.
  • Effective communication and facilitation skills across teams and organizational levels.


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