IT Human Resources Leiden, Zuid-Holland
My client is seeking people who have demonstrated proven success in roles and through abilities in: Equipment Qualification, Computerised System Validation, Laboratory/Facility Instrument Qualification, Cloud Validation, Risk management and Quality Management. This is a hybrid position in Europe - it will require 50% on-site working in the Netherlands, the rest is remote. This role requires experience in facility, utilities and manufacturing equipment qualification - please only apply if you have this experience. Essential requirements: Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices. It is preferable that the candidate should have knowledge on aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance, or manufacturing compliance. Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing. Good to have Knowledge on Laboratory Systems Qualification and Facilities Qualification Knowledge on Analytical lab instruments Knowledge on Instrument integration using RS232, USB, wireless etc Good Knowledge on Calibration of instruments Understanding of key pharmaceutical compliance regulations like Computerised System Validation, 21 CFR part 11, GxP, GAMP 5, SOX IT, Data Privacy, Data Integrity, and Information Security Knowledge on new regulations Enable innovations, Quality by design, CSA Subject matter expertise in areas such as Quality Management, Document management, Software Development Life Cycle, Configuration Management and Change Management Knowledge of System and Functional Risk assessment/management, defining risk mitigation plan Knowledge and hands on experience conducting periodic review Knowledge of various Validation tools and templates used throughout the pharmaceutical industry. Technical Writing Experience Work according to SOPs and GMP Regulations For immediate consideration, please send me your latest CV.