CSV & Equipment Compliance Manager

📋 Description

• Identify and plan CSV tasks in collaboration with LGC IT, Quality Assurance, and operational
• Complete risk-based CSV activities following GAMP 5, EU GMP Annex 11, and FDA 21 CFR Part 11
• Prepare, review, and approve CSV documentation, including requirements specifications, system
• Coordinate and support software validations and equipment qualifications; assist in site
• Act as Deputy System Administrator for computerized systems/equipment to ensure data integrity and
• Provide expert support during internal and external audits on CSV and Data Integrity topics

🎯 Requirements

• At least 4 years of experience selecting, validating, and qualifying computerized systems in a
• Bachelor’s degree or equivalent experience (or higher) in Computer Science, Information Technology
• Training or certification in Computer System Validation (CSV), GAMP 5, or similar regulatory
• Strong dedication to compliance and quality standards
• Excellent communication skills, reliability, and ability to work collaboratively in
• High sense of responsibility and structured approach to problem-solving