Computer System Validation Specialist
6 days ago
Key Responsibilities:
- Define overall validation strategy and approach for Digital Clinical CSV projects, aligning with QA policies and best practices.
- Author key validation documents, including Validation Plans, Validation Summary reports, and Test Plans.
- Advise project and technology teams on validation and data integrity best practices and approaches.
- Collaborate with GCP QA on process definition and improvement, authoring and revising CSV-related SOPs.
- Coordinate with external Vendors on Validation and 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, supporting QA and business teams during inspection activities.
Requirements:
- 10+ years of computerized system validation experience with a primary focus on GCP, GVP, and GLP.
- 5+ years of validation team leadership, providing coaching, mentoring, and coordinating validation efforts within larger projects.
- Proven experience in leading sustainable and nimble validation efforts for SaaS/PaaS GxP systems and cloud infrastructure.
- Working knowledge of CSV, data integrity, and ICH guidance related to computerized systems in clinical trials.
- Solid project management skills.
- Experience with Veeva platforms is a major plus.
- Extensive hands-on work with Validating GxP platforms such as RIM, QMS, and SAS.
- High-level experience with RIM processes.
- Experience supporting regulatory inspections related to computerized systems.
- Excellent communication skills.
- Demonstrated experience in authoring key validation deliverables.
- Experience with paperless validation preferred.
- Bachelor's degree in computer science, biotechnology, engineering, or equivalent.
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