PRole: System Validation, Platform Qualification /ppLocation: Spain(100% Remote) /ppClient: Infosys /ppSal: Market Range /ppPermanent full-time position /ppbr/ppRequirements and number of open positions /ppbr/pp3-5 years- 2 Positions in Open /pp5-10 Years- 2 Positions in Open /pp10+ years
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- 2 Positins in Open /ppbr/ppRole Overview /ppWe are looking for a highly experienced Validation resource with 10+ years of experience in Computerized System Validation (CSV) within the Life Sciences domain.
The candidate will lead end-to-end validation activities for enterprise-level software systems and manage teams, stakeholders, and delivery for global programs.
/ppbr/ppKey Responsibilities /pp - Lead end-to-end validation lifecycle (Planning, Risk Assessment, Testing, Release, Periodic Review) /pp - Drive validation strategy for enterprise programs across regions (Europe/General) /pp - Manage validation teams, allocate work, and ensure timely delivery /pp - Act as primary point of contact for client stakeholders and leadership /pp - Lead governance, status reporting, and escalation management /pp - Author and review validation deliverables (URS, FRS, IQ/OQ/PQ, RTM, Validation Report) /pp - Ensure compliance with 21 CFR Part 11, EU Annex 11, Data Integrity (ALCOA+)



/pp - Manage quality processes (Deviation, CAPA, Change Control) /pp - Support regulatory audits and inspection readiness /pp - Mentor and coach junior resources, build capability within the team /pp - Drive continuous improvement and standardization of validation processes /ppbr/ppManagerial Skills /pp - Team leadership and people management /pp - Stakeholder and client relationship management /pp - Program and project management for global validation initiatives /pp - Risk and issue management with mitigation planning /pp - Resource planning and capacity management /pp - Governance, reporting, and executive communication /pp - Budget awareness and delivery management /pp - xhfqzwm Cross-functional coordination across IT, QA, Business and Vendors /ppbr/ppRequired Skills Competencies /ppbr/pp - 10+ years of experience in Life Sciences CSV/CSA /pp - Exposure to cloud/SaaS validation /pp - Strong experience in enterprise systems (SAP S/4HANA, Veeva Vault, LIMS, QMS etc.) /pp - understanding of SDLC and validation lifecycle /pp - Understanding on regulatory guidelines (GAMP 5, GxP, 21 CFR Part 11, EU Annex 11 etc.) /pp - Experience in risk-based validation and CSA approach /pp - Experience working with US and European clients and regulated environments /pp - Strong documentation, communication, and leadership skills.
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📌 Sr. System Validation, Platform Qualification Engineer (Pontevedra)
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📍 Pontevedra