Lead and execute qualification and computer system validation (CSV) activities for Quality Control (QC) laboratories, ensuring data integrity and regulatory compliance
Job Summary
Lead and execute qualification and computer system validation (CSV) activities for Quality Control (QC) laboratories, ensuring data integrity and regulatory compliance.
Author and revise WIs/SOPs related to equipment lifecycle, CSV, and data integrity, and plan and steer (re-)qualification campaigns involving multiple departments.
Guide and supervise cross-functional project teams, coordinate timelines and resources, and train and mentor colleagues on CSV, Annex 11/Part 11, data integrity, and qualification best practices.
Matching Summary
Lead and execute qualification and computer system validation (CSV) activities for Quality Control (QC) laboratories, ensuring data integrity and regulatory compliance.
Skills & Requirements
Must-have
GMP environment
Computer System Validation
Data Integrity controls
Analytical instrument qualification
Lifecycle documentation
Nice-to-have
Cross-functional coordination
Project planning
Problem-solving skills
Lab automation
Quality systems and tools
Key Requirements
MSc or PhD in Natural Sciences, Engineering, Computer Science, or related field
Bachelor’s degree with substantial, relevant GMP experience
Proven experience qualifying laboratory equipment in a GMP environment
Hands-on CSV experience for laboratory/software systems