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.
Qualifications/Skills
Required Experience & Knowledge
• You have a 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.
Since 1995, CVO-EUROPE’s multidisciplinary team has been supporting life science companies at every stage (design, validation, operation, digital transformation) of critical activities that may affect product quality, data integrity and patient health, whilst ensuring the compliance of their systems, equipment, processes and data.
With its comprehensive service range (consulting, shared service center, auditing, and instructional engineering), the CVO-EUROPE Group is committed to bringing its clients effective and innovative solutions whilst staying true to the human values that have characterized it from the outset.
Nom :Sarah Cornez
Email :sarah.cornez@cvo-europe.com
Tél. :+32472072341
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