What are the responsibilities and job description for the CSV Consultant position at Katalyst CRO?
Roles & Responsibilities
- Ex-Pharmaceutical preferred.
- Experience in the Pharmaceutical, biotechnology, or medical device industry.
- 2 years' experience with System Development Lifecyle.
- 3 years' experience in Computer System Validation (Based on the role selected).
- Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.
- Knowledge of FDA guidance's and industry standards (i.e., GAMP).
- 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, systems and 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.