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Senior IT Validation Expert
hace 2 meses
About Roche
At Roche, we're a global research-focused healthcare group with over 100,000 people across 100 countries. We're dedicated to pushing back the frontiers of healthcare and making a meaningful difference in people's lives.
Job Summary
We're seeking a highly skilled Senior IT Validation Expert to join our team. As a key member of our IT department, you'll 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 other deliverables), 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 frameworks and processes, propose and use tools.
- Provide training and validation/quality knowledge/experience exchange support.
- Prepare recommendations for process optimization in their area of influence.
Requirements
- Minimum 6+ years of experience in IT & Software Validation (CSV, GAMP5).
- Excellent 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, i.e., 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
- Dedicated training budgets and many opportunities for personal and professional self-development (training, conferences, diversified career paths, etc.).
- A workplace that supports innovation and new ideas.
- Attractive benefits & business travel opportunities.
- Work in a great team with international colleagues on exciting topics to shape the IT behind the healthcare of tomorrow.
