Specialist, IT Validation Services
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Job Description
Structured overview of role & requirementsAbout This Role
Support execution of Computer Systems Validation (CSV) activities across multiple Pharma GxP applications to ensure 'fit for use' before production release.
Author CSV deliverables including Plans and Summary Reports; support risk and impact assessments for validation scope determination.
Review and approve application change tickets ensuring change management compliance; conduct periodic compliance reviews and provide status updates to management.
Minimum Requirements
Bachelor's degree required.
4-6 years experience in IT Quality, Computer System Validation, or related field.
Good knowledge of IT testing practices and methodologies in Pharma GxP environment; familiarity with test management tools (e.g., ALM).
Work Experience Required: 4-6 years; experience with validation of systems like CTMS, eTMF, ServiceNow, Veeva, Qumas, SAP, MES, REMS, or Regulatory systems is desirable.
Ideal Candidate Profile
Experience working within established CSV processes and able to operate with minimal supervision.
Strong understanding of Pharma GxP validation requirements including risk assessments and change management.
Comfortable authoring clear validation documentation and providing regular compliance status updates to management.