Computer System Validation Specialist @ Avenga

1 week ago


Remote, Czech Republic Avenga Full time
  • 3+ years of experience in IT & Software Validation (CSV, GAMP), preferably in pharma environment including;
  • Leading validation for projects and systems maintenance;
  • Authoring validation plans, reports and deliverable registries;
  • Authoring or reviewing validation related deliverables, records and other evidences;
  • Maintenance and support of applications under global inspection agencies, CFR 21 FDA Part 11, Annex 11;
  • Ability to work collaboratively in cross-functional teams to achieve milestones and goals;
  • Communication skills, English language mandatory (B2).
,[Determine validation approach, identifies deliverables needed or impacted by a project / enhancement / or change for GXP computerized systems;, Be responsible for the review of software documentation according to CSV corporate SOP's, and regulatory guidance;, Authorize validation plans/reports, reviews test plans/reports (and other deliverables) to assess and notify that the system is ready to go life;, Verify testing plans, activities, deliverables and records, provide consultancy on test related deviations and corrective actions according to approved procedures;, Support system audit/inspection preparation and execution as CSV subject matter expert;, Support system maintenance with validated state and permanent audit readiness;, Implements relevant framework and processes, propose and uses tools.] Requirements: CSV, Jira, ServiceNow Additionally: Sport subscription, Training budget, Private healthcare, International projects.

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