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Senior IT Validation Expert

hace 2 meses


Madrid, Madrid, España Roche A tiempo completo

About the Role

We are seeking a highly skilled Senior IT Validation Expert to join our team at Roche. As a key member of our IT department, you will play a critical role in ensuring the validation of our computerized systems meets the highest standards of quality and regulatory compliance.

Key Responsibilities

  • Determine validation approaches and identify deliverables needed or impacted by a project/enhancement/change for GxP computerized systems.
  • Review system documentation according to Roche CSV SOPs and regulatory guidance.
  • Develop validation plans/reports, review test plans/reports, and assess, authorize, and notify that the system is ready to go live.
  • Verify testing plans, activities, deliverables, and records, provide consultancy on test-related deviations and corrective actions according to approved procedures.
  • Support deviation investigations to identify root causes and define corrective and/or preventative actions.
  • Support system audit/inspection preparation and execution as CSV subject matter expert.
  • Support system maintenance and enhancement activities, ensuring the validated state is kept, and it is audit and inspection ready.
  • Lead and author system periodic reviews according to company procedure.
  • Implement relevant framework and processes, propose and use tools.
  • Provide training and validation/quality knowledge/experience exchange support.
  • Prepare recommendations for process optimization in his/her area of influence.

Requirements

  • Minimum 6+ years of experience in IT & Software Validation (CSV, GAMP5).
  • Leading validation for projects and systems maintenance.
  • Authoring validation plans, reports, and deliverable registries.
  • Reviewing validation and testing-related deliverables, records, and other evidence, including relevant system documentation.
  • Maintenance and support of applications under global audit and inspection agencies.
  • Good knowledge of Food and Drug Administration regulations/guidance (e.g., CFR 21 FDA Part 11, Annex 11, EU GMP Annex 1, GxP practices).
  • Good understanding of system and data risk assessment.
  • Ability to work collaboratively in cross-functional and agile teams to achieve milestones and goals.
  • Effective communicator with excellent verbal and written communication skills - English language mandatory.
  • Assertiveness, conflict management skills, leadership skills, and ability to work with diverse personality/cultures.
  • General understanding of Agile Methodology (Framework, e.g., SAFe, Scrum), previous experience would be an advantage.
  • Bachelor of Science or equivalent in computer science, engineering, life sciences, or related field.

What We Offer

We offer dedicated training budgets and many opportunities for personal and professional self-development (training, conferences, diversified career paths, etc.).