CSV Consultant

Responsibilities

• Write and execute documentation for all aspects of validation deliverables (requirements, compliance/validation plans, test protocols, test summary reports, compliance/validation reports)
• Review system test and user acceptance test scripts, traceability matrix, and design specifications
• Apply QA methodologies: design, review, and approve test plans, systems, UAT test scripts, and test procedures

Requirements

• Ex‑Pharmaceutical preferred; experience in pharmaceutical, biotechnology, or medical device industry
• 2+ years’ experience with System Development Lifecycle
• 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)
• 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