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QA operation specialist

Introduction


Are you looking for the next step in your career? You have an experience, in Quality?

Keep on reading, this is for you!

For one of our clients active in the pharmaceutical industry, XPE Pharma & Science is looking for a QA Operation Specialist. 



Company/Department


As Quality Assurance Specialist, you 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, you 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 be reporting to the Head of Quality:

Your main challenges: 

  • 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


Your profile

• You have a good knowledge of cGMP in a regulated environment (ICH Guidelines)

• You have an experience in QA of minimum 2 years, and a scientific education background

• You have an excellent accuracy and attention to detail

• Your are highly flexible and adaptable, and able to work independently in a fast paced multitasking environment

• You have a very good knowledge of French and English



Offer


• An exciting experience in leading pharmaceutical company;

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

• A fix term contract.


Information


This job is made for you? Don't delay and apply by sending me an email.

You are not ready to apply or have questions? Don't hesitate to contact me and we will discuss in total confidence. 

Julie Mertens

Life-science recruiter - Permanent Placement eXPErt Technical

julie.mertens@xpe-group.net

010/80.71.12


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