What are the responsibilities and job description for the CSV Engineer position at Katalyst Healthcares and Life Sciences?
Responsibilities :
- Apply your professional knowledge of 21CFR Part 11 systems validation and regulatory compliance with a range of computerized systems.
- Perform as a project execution and thought leader to provide regulatory guidance regarding compliance with intended specifications.
- Engage in value-add relationships to deliver outstanding project outcomes and identifying new more optimal opportunities for processes and procedures.
- Share best practices, industry knowledge, and personal expertise to educate client in formal and ad hoc settings Requirements.
- Demonstrated capabilities in creating validation documentation, including GxP Assessments, Validation Plans, Risk Assessments, Requirements / Design / Functional Specifications, IQ / OQ / PQ Protocols, Reports, Traceability Matrix, and Standard Operating Procedures.
Requirements :
