Lead and execute qualification and computer system validation (CSV) activities for Quality Control (QC) laboratories, driving lifecycle management of analytical instruments and non-analytical utilities
Job Summary
Lead and execute qualification and computer system validation (CSV) activities for Quality Control (QC) laboratories, driving lifecycle management of analytical instruments and non-analytical utilities.
Author and revise WIs/SOPs related to equipment lifecycle, CSV, and data integrity, while planning and steering (re-)qualification campaigns involving multiple departments.
Guide and supervise cross-functional project teams, train and mentor colleagues on CSV, Annex 11/Part 11, data integrity, and qualification best practices, and collaborate with internal partners and external vendors.
Matching Summary
Lead and execute qualification and computer system validation (CSV) activities for Quality Control (QC) laboratories, driving lifecycle management of analytical instruments and non-analytical utilities.
Skills & Requirements
Must-have
Equipment Qualification IQ/OQ/PQ
Computer System Validation (CSV)
Data Integrity Controls
GMP and site standards
Lifecycle documentation authoring
Cross-functional coordination
Nice-to-have
QC quality systems and tools
Lab automation and integration
Databases and virtualization
Networked lab systems
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 GMP
Hands-on CSV experience for laboratory/software systems