CSV Specialist

Katalyst Healthcares & Life Sciences

🇺🇸 United States

On-site

2 weeks ago

Not enough detail in this posting to match

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.

CSV Specialist · Katalyst Healthcares & Life Sciences