Validation & CSV - Katalyst Healthcares & Life Sciences
South Plainfield, NJ 07080
About the Job
Responsibilities:
- Hands-on CSV specialist on assigned projects, responsible for the creation, execution and coordination of the project's CSV deliverables.
- CSV advisory for the planned projects.
- Training of testers and approvers of CSV processes and systems.
- Perform Protocol Exception Assessments and Resolutions.
- Provide support to testers, as needed, with validation questions.
- At all times, exemplify the highest level of business and personal integrity.
- Must be able to work nights & weekends.
- 3-5 years experience as a CSV specialist within the Life Sciences Industry.
- 1-2 years experience with ERP validation, SAP S/4 HANA experience preferred.
- Knowledgeable in US and Global Computer system Validation requirements.
- Knowledge of GAMP 5 methodology.
- Experience with ValGenesis, preferred.
- Detail-oriented with ability to accomplish objectives.
- Demonstrated ability to work independently.
Source : Katalyst Healthcares & Life Sciences