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Validation Lead

Validation Lead

Katalyst Healthcares and Life SciencesFoster City, CA, United States
2 days ago
Job type
  • Full-time
Job description

Responsibilities :

  • 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 Client 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.

Requirements :

  • Testing / Validation for System Implementations - Knowledge and prior experience in testing and validation for medium to large system implementation.
  • Experience in working with SaaS and Cloud systems in a GxP environment; Proficiency with Client 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.
  • bility to quickly adjust to new technologies, workflows, and environments.
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    Validation Lead • Foster City, CA, United States