|Title: Computer System Validation Specialist|
Type of role: Contract (1099, C2C or W2)
Duration: 10+ months
Location: Palo Alto, CA
Our client is looking for a CSV Specialist with GxP systems experience. Experience with Argus and Change Management Process is must have.
Minimum 6+ years of experience in computerized system validation within a regulated environment.
- Proven ability to lead validation activities of complex IT GxP projects (Experience validating Argus and experience with Change Management Process)
- Possess system quality and compliance knowledge of GxP regulations (21 CFR Part 11, Annex 11 & GAMP5)
- Hands-on authoring/ review/ approval of computer system validation deliverables.
- Author Validation Plan, Design Specification, IQ, OQ & PQ Protocols, Traceability Matrix and Validation Summary Reports for assigned projects.
- Manage authoring of Risk Assessments and change management.
- Manage authoring, dry running, & review & approval of IQ, OQ and PQ test scripts.
- Manage preparation of all validation deliverables for presentation to QA for approval.
- Experience in creation/maintenance & implementation of SOPs.
- Experience with Validation Testing (test execution), experience in Pharma Domain.
- Write up and manage resolution and final disposition of all Deviations identified during test execution.
- Demonstrated strong organizational, verbal, written and presentation skills.