Nr ref.: /APD/CSV/remote/01
- 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 SOPs, 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.
- 4+ 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 (C1).