What are the responsibilities and job description for the CSV Specialist position at Katalyst CRO?
Requirements
- Min 5 years of CSV experience.
- experience supporting validation of GxP GEN AI based solutions is a major plus
- experience supporting mergers/acquisitions/divestitures is a major plus
- Experience in the Pharmaceutical, biotechnology, or medical device industry
- Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.
- Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports
- Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs.
- Experience in QA Methodologies, designing, reviewing and approving Test Plans, System/UAT test scripts and Test procedures.
- Strong verbal and written communication skills.
- Ability to work as a team player, lead a team or accomplish tasks without supervision.
- Ability to work with remote teams and support several changes/projects simultaneously.
- Ability to provide Validation guidance, timely reviews, and escalations to TQ management.