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System Validation and Compliance Lead

2 tygodni temu

Kraków, Lesser Poland Cytiva Pełny etat
Key Responsibilities

As a Computerized System Validation (CSV) specialist, your key responsibilities will include:

  • Providing CSV support in key global projects concerning computerised systems, ensuring compliance with QMS and regulations.
  • Reviewing and approving GxP assessment and Validation Master Plans, and authorising change controls where applicable.
  • Supporting projects and ongoing maintenance of systems.
  • Working closely with the Biopharma QARA CSV IT and IT Compliance Manager to roll out CSV training and education.

You will also have the opportunity to develop your skills and expertise in areas such as Medical Devices QMS and regulatory requirements, including FDA CFR 21 820 and ISO 13485 and ISO 9001.