Currently working exclusively with a Biotech Client in the Netherlands who are in need of a QA Validation Specialist ASAP! You will support the DI Manager and QA Validation team across several different projects: support reduction of backlog; support Engineering and Validation activities from documentation perspective; and assist with Data Integrity tasks according to GMP regulations. Responsibilities:
Data Integrity Tasks: Performs annual system administrator audit trail review of GMP computerized and electronic systems within laboratory, manufacturing, and engineering departments; user access reviews; design electronic data review for manufacturing and create work instructions using available templates as reference.
Direct engagement with Engineering /Maintenance and Calibration/ Validation departments and manufacturing shop floor operations to support and provide cGMP guidance, document review and approval and advice regarding documentation quality practices.
Quality review and approval of validation documentation (FAT, SAT, IQ, OQ, PQ, etc.)
Creates detailed work instructions for electronic data access and review process for manufacturing systems.
Supports the update of existing site documents as needed, to implement the electronic data review process for manufacturing systems.
Minimum of 5 years proven experience in a QA Validation/CSV role in Biotech/Pharma sector.
Knowledge of data integrity related to quality control data from laboratory instrumentation and operations equipment and associated computer systems.
Solid knowledge of current GMP
Understanding of 21CFRPart 11,Annex 11, 15, MHRA ‘GXP’ Data Integrity Guidance and Definitions.
Start Date: ASAP Duration: 6 months (extension likely) On vs Off site: Onboarding must be done on-site for initial month, thereafter can be flexibility to WFH when completing documentation etc.
Interested? Get in touch by sending your CV to email@example.com, as interview + offer will happen this week.