Validation Lead; Computer System Validation

Job Details

• Experience in the Pharmaceutical, biotechnology, or medical device industry
• 2+ years' experience with System Development Lifecycle
• 3+ years' experience 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 (Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports)
• Experience in QA Methodologies, designing, reviewing and approving User Stories, Test Plans and Reports, System and UAT test scripts, Test procedures, Traceability Matrix, and Design Specs
• Strong verbal and written communication skills
• Ability to lead a team
• Ability to work with remote teams and support several changes/projects simultaneously
• Ability to provide validation guidance, timely reviews, and escalations to TQ management
• Ability to work with global project teams during the initial project planning phases
• Ability to provide guidance on validation strategy and be able to handle the highly fluid state of the project