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cGxPServe
Validation Lead
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Summary
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 5 years in computer systems validation and testing.
- Flexibility to work across time zones, manage multiple projects, and travel as needed, with Life Sciences or Pharma experience preferred.
- BE, Comp Science, BCA, BSE computer science.
- 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.
- Thorough knowledge of GxP compliance, including 21 CFR Part 11 and CSA guidelines.
- Proficiency with Client ALM (Application Lifecycle Management).
- Methodologies:
- Experience with Waterfall, Iterative, and Agile methodologies.