Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Roles & 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 across time zones, manage multiple projects, and travel as needed, with Life Sciences or Pharma experience preferred.
Requirements:
- Experience and education in Life Sciences or Pharma preferred.
- 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).
- Experience with Waterfall, Iterative, and Agile methodologies.
- Industry-specific Experience..
- Adaptability: Ability to quickly adjust to new technologies, workflows, and environments.
- Communication: Excellent communication skills, both verbal and written.
- Flexibility to work in different time zone hours and travel as required.