Overview
On Site
Depends on Experience
Full Time
Skills
Computerized System Validation
Regulatory Compliance
HP ALM
Application Lifecycle Management
GxP
SaaS
Job Details
Validation Lead
Foster City, CA 94404 (Onsite)
FTE / CTH / Contract
Job/ Role Description:
- Proven leadership in testing, validation for medium to large system implementations, ensuring GxP compliance and quality delivery
- Extensive experience with Waterfall, Iterative, and Agile methodologies, guiding teams to successful project outcomes
- Proficient in Microsoft Office Suite (Project, Visio, Excel, PowerPoint) for project management and reporting
- Expertise in HP ALM for managing testing cycles, with broad technical knowledge of SaaS and Cloud systems in a GxP environment
- Strong understanding of 21 CFR Part 11, CSA guidelines, with 2+ years in computer systems validation and testing
- Flexibility to work different time zones, manage multiple projects, and travel as needed
Experience & Skills:
- Testing/Validation for System Implementations - Knowledge and prior experience in testing and validation for medium to large system implementations
- Experience in working with SaaS and Cloud systems in a GxP environment; Proficiency with HP ALM (Application Lifecycle Management)
- Thorough knowledge of GxP compliance, including 21 CFR Part 11 and CSA guidelines
- Methodologies: Experience with Waterfall, Iterative, and Agile methodologies
- BE / BCA / BSE in IT / Computer science / Biotech/Pharma with 10+ years of experience
- Ability to quickly adjust to new technologies, workflows, and environments
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