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Superviseur de production

Introduction


As solution provider within the Life science sector , XPE Pharma & Science is looking for a QA Operation Specialist for a client in Brussels!



Company/Department


The Quality Assurance Specialist will be working as part of the Quality Assurance Department and ensure that the products are manufactured, stored and packaged in accordance with cGMP

You  will also support the development of GMP training packages and, if necessary, delivery of training.

Under the direction of the reporting manager, he / she will continuously improve QA and Compliance systems, strengthen quality awareness and investigate quality issues using applicable process improvement and problem solving techniques to assure successful outcomes of Company and external Health Authority inspections.


Function information


As QA Specialist you will bereporting to the Head of Quality:

Main tasks: 

  • Investigation and closure for the Deviation and the Out Of Specifications
  •  Change Control initiation and implementation
  •  CAPA initiation and implementation / Initiation et Implémentation de CAPA
  • Documentation and records review
  • Procedure, Master Batch Record, Specifications… / Procédure, Master Batch Record, Specifications…
  • Batch records and associated documents after production
  • Control Cleaning Records
  • Maintain the calibration program and the monitoring for the facilities up to date
  •  Documentation System Management
  • Traceability




Requirements


Specific skills required

• Good knowledge of cGMP in a regulated environment (ICH Guidelines)

• Excellent accuracy and attention to detail

• Excellent interpersonal skills

• Working knowledge of MS office packages (Word, Excel, Power Point) and TrackWise® System is in asset

• Strong problems solving skills, issue resolution and root cause analysis

• Highly Flexible and Adaptable. Able to work independently in a fast paced multitasking environment

• Language: French, English knowledges is an asset



Offer


• An exciting experience in leading pharmaceutical company;

• An attractive salary package with company car and extra-legal advantages;

• A fix term contract.


Information


Asmae El Addad

Asmae.eladdad@xpepharmascience.com

0492.231817


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