AKKODIS Belgium is looking for an experienced person in a pharmaceutical environment in the field of Commissioning & Qualification.
Tasks
• Act as C&Q to provide guidance and to manage suppliers and all C&Q activities for the systems, from design to field execution and to summary report approval.
• Draft, coordinate review and approval of C&Q documents (URS/ QRA/ SRA/ ERES/DQ/FAT/SAT/IQ/OQ/ VP..).
• Generate and review Change Controls related to C&Q.
• Drive verification testing, protocol execution, walk-downs, verification of system drawings and troubleshoot as required.
• Responsible for the Planning, Tracking and Reporting of C&Q status and risks/issues for the selected systems.
• Conduct deviation investigation and resolution, take appropriate corrective actions as required.
• Responsible for the Planning, Tracking and Reporting of C&Q status and risks/issues for the selected systems.
• Ensure Start-up of equipment/ system is completed in a safe and coordinated manner.
Profile
• Bachelor or Master's degree in Engineering or in Life Sciences with relevant experience.
• Experience delivering Commissioning and Qualification for Pharmaceutical / Biotechnology projects.
• Knowledge of GxP.
• Understanding of a risk-based approach to C&Q.
• You are fluent in French and English.
Raja BOUDAIA -Talent Aquisition Officer Akkodis
Raja.BOUDAIA@akkodis.com