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 Plant Engineering and Validation activities from documentation perspective; and assist with Data Integrity tasks according to GMP regulations.
- 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 Plant 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.