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Job summary
A leading life science consultancy based in Ireland is seeking a professional with strong expertise in Computer Systems Validation (CSV) to identify and manage risks associated with GxP IT systems. The ideal candidate will have experience in pharmaceutical or similarly regulated environments and will demonstrate technical skill in preparing CSV deliverables. This role involves working closely with IT and process owners to enhance compliance through effective risk management and continuous improvement initiatives.
Qualifications
Experience in Pharmaceutical or Life Science regulated environments.
Practical knowledge of IT Qualification (IQ) activities.
Familiarity with GAMP 5.
Responsibilities
Identify and mitigate risks in GxP IT systems.
Prepare and execute validation protocols and reports.
Provide support for compliance and quality deviations.
Skills
GxP compliance
Computer Systems Validation (CSV)
IT Infrastructure knowledge
Data Integrity regulations
Education
Higher education in Computer Science or related field
Job description
A leading life science consultancy based in Ireland is seeking a professional with strong expertise in Computer Systems Validation (CSV) to identify and manage risks associated with GxP IT systems. The ideal candidate will have experience in pharmaceutical or similarly regulated environments and will demonstrate technical skill in preparing CSV deliverables. This role involves working closely with IT and process owners to enhance compliance through effective risk management and continuous improvement initiatives.