What are the responsibilities and job description for the Computer System Validation - CSV Engineer position at Katalyst Healthcares and Lifesciences?
Job Details
Roles & Responsibilities:
- Minimum 8 years of relevant experience; can work independently and guide/mentor Junior resources.
- Experience in the Pharmaceutical, biotechnology, or medical device industry with System Development Lifecyle in Computer System Validation 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.
- Ability to Review Automated Test script 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.
- Hands on experience with validation of Data Solutions is preferred.
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