CSV Consultant Katalyst Healthcares & Life Sciences - 4.0 Little Rock, AR Job Details Contract 1 day ago Qualifications Biotechnology GAMP Team leadership Test Case Documentation (Quality assurance practices) Pharmaceutical regulatory compliance Writing skills Mid-level 3 years Data summary reports Quality reports Pharmaceutical company experience System validation Quality assurance experience within pharmaceutical industry Compliance documentation User acceptance testing Leading team collaboration initiatives System development Test validation method Communication skills Test Planning (Quality assurance practices) Validation design FDA regulations

Full Job Description 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.