GxP Compliance Specialist for Computerized Systems

2 weeks ago


Cork, Cork, Ireland TN Ireland Full time

TN Ireland seeks a talented Computer System Validation Specialist to join our team and support our efforts in ensuring the compliance of our computerized systems.

Key Qualifications:

To be successful in this role, you will need a bachelor's degree in computer science, engineering, or other sciences, minimum 2-3 years of experience working with automation and/or computerized system validations, direct experience in validation of computer/automation/software validation, and strong written and oral communication skills.

Responsibilities:

  • Manage all aspects of CSV activities for out-of-the-box, configured (GAMP 5 category 4), and custom software (GAMP 5 Category 5).
  • Review vendor documentation and previously executed CSV work to determine if any gaps exist.
  • Qualify vendors of computerized systems and draft/review/revised CSV SOPs.


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