What are the responsibilities and job description for the Validation Lead position at Katalyst CRO?
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.
- 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.
- Ability to quickly adjust to new technologies, workflows, and environments.