Senior IT Validation Expert
hace 1 semana
About Roche
Roche is a global leader in pharmaceuticals and diagnostics, committed to improving people's lives. We believe that diversity, equity, and inclusion are essential to our success. Our diverse teams work together to understand the complex needs of people around the world, driving innovation and exceptional care.
The Position
We are seeking a highly experienced Senior IT Validation Professional to join our team. The ideal candidate will have a strong background in IT and software validation, with a minimum of 6+ years of experience in:
- Leading validation 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 communication skills 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 an advantage
Requirements
The successful candidate will have a Bachelor of Science or equivalent in computer science, engineering, life sciences, or a related field.
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