CSV Consultant

Responsibilities

• Experience in writing and executing documentation for all aspects of the validation deliverables (requirements, compliance/validation plans, test protocols, test summary reports, compliance/validation reports)
• Experience in reviewing system test and user acceptance test scripts, traceability matrix, and design specifications
• Experience in QA methodologies, designing, reviewing and approving test plans, systems, UAT test scripts, and test procedures

Requirements

• Ex‑Pharmaceutical preferred; experience in the pharmaceutical, biotechnology, or medical device industry
• 2+ years’ experience with System Development Life Cycle
• 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 and industry standards (e.g., GAMP)

Skills

• 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