Nos offres d'emploi

Deviation Writer Engineer (M/F)


Belgique

CVO/BE/ING/1027

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.

To support our development, we are looking for :

Deviation Writer Engineer (M/F)

Permanent contract

Responsibilities
Deviation writer is responsible of deviation management in production area and responsible to investigate the complaint of customer:

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.

OUR OFFER

• 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.

Interested ? Don’t hesited to send your CV via our websit




publication date : 01/03/2019

  1. Mrs Mr



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