What are the responsibilities and job description for the Computer System Validation Lead position at Arrayo?
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As a validation strategist, you will lead the development and execution of compliant and nimble validation strategies for cloud based (SaaS, PaaS) clinical, regulatory, and safety applications.
Responsibilities :
- Define overall validation strategy and approach for Digital Clinical CSV projects in a digital context (cloud, automation, AI) and in alignment with QA policies.
- Author key validation documents : Validation Plans, Validation Summary reports, Test Plans, etc.
- Advise project and technology teams on validation and data integrity best practices and approaches.
- Collaborate with GCP QA on process definition and improvement, author and revise CSV related SOPs.
- Coordinate with external Vendors on Validation and general IT operations support tasks.
- Coordinate CSV activities (UAT, document reviews) for clinical digital projects.
- Liaise with GMP CSV team to harmonize and streamline validation practices.
- Provide training on validation process and templates.
- Oversee CSV readiness for inspections and audits, support QA and business team during inspection activities.
Requirements :
J-18808-Ljbffr
