Deviation Writer Engineer (M/F)
With more than 350 consultants, CVO-EUROPE provides expertise in every activity that may affect patient health, product quality or data integrity.
CVO-EUROPE is an international group with business divisions in France, Belgium, Switzerland, and the USA.
Primary Tasks & Responsibilities:
• To define the validation strategies through the change control process (RPC);
• Management of deviations related to the activity in the building;
• Definition of corrective and preventive actions;
• Initiate and describe the deviation in SAP system;
• Investigate process deviations to identify root-cause (operator interviews, 5Why’s, 6M, gemba tour, …);
• Investigate Complaint;
• Propose adequate CAPAs;
• Complete the deviation in SAP system, and collect annexes;
• Generate standard KPI to follow the management of deviations;
• Guarant of the deviation closure within delay.
• You have a minimum bachelor degree with experience or Master degree Pharmacist, bio-engineer, (micro) biologist, industrial engineer ;
• Knowledge of good manufacturing practices (cGMP), pharmaceutical production environment, SAP knowledge and deviation management system would be a good plus for the function.
• Very good knowledge of French, good knowledge of English.
• You have a good organizational, reporting and communications skills. You have a strong analytical skills and able to work in team.
• You are mobile and flexible (the company is located on Wavre in Belgium).
• CVO-EUROPE is an international Leader Company in the Engineering, Validation and Quality sector, which offers you interesting project. A strong corporate culture ensuring a personal and professional blooming and self-fulfillment.
• Overall trainings and a personal career management.
• An excellent salary package with lot of extra legal advantages.