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QA GMP Specialist Belgium,  

Keyrus Biopharma (company)

Posted on : 26 February 2017

Project Description

Job Description
  • We are urgently looking for a junior QA GMP Specialist, for one our clients, who is willing to take an exciting next step in their career.
  • The assignment consists of reviewing Batch records and handling all the admin for compliance, including tasks related to the manufacturing pilot plant, during the transition between start-up and routine operations. 
  • The manufacturing plant is a multi-product facility, with different products/manufacturing campaigns that are run per year.  
  • The position would entail being part of a manufacturing organization and operations. 

The candidate will primarily work on the finalization of GMP documentation arising from production, as well as on compliance tasks such as (but not an exhaustive list): 
  • Executed Batch record review and associated deviations
  • Cleaning check lists review
  • Set up archiving process inside the building and follow up on a routine basis
  • Procedures Revision to implement continuous improvement
  • On-Line training creation for specific departmental/business unit procedures
  • Change Control creation in a tracking system and follow up of related actions
  • Building Access and Logbooks management (creation and closure)  

  • Master in Biological/Biomedical Sciences or equivalent
  • Good quality understanding in GMP-regulated environment.
  • Knowledge of QMS is an asset
  • Able to learn quickly
  • Organized and with a technical mindset.
  • Must be able to demonstrate xcellent communication skills 
  • Autonomous, able to work under limited supervision, with an innovative flair
  • Flexibility to adapt to moving timelines
  • Fluent in French is a must and good knowledge of English is needed  

Our offer: 
  • You will receive a competitive based salary depending on your education and experience in an attractive package of extralegal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization &). 
  • Each employee will be welcomed with a varied integration program. 
  • We invest considerable time and resources in training our staff (technical and non-technical courses). 
  • You will join a dynamic and international environment with enthusiastic and professional colleagues. 

Who we are
  • Our company is a European full-service Contract research organization (CRO) providing biopharmaceutical, nutritional, cosmetic, animal health and medical device industries with a broad range of clinical research services.
  •  From early- to late-stage clinical development, including regulatory affairs, project management, clinical monitoring, scientific and medical support, site management, biostatistics, data management, product safety, quality assurance and medical & scientific communication.


Brabant Walloon Belgium

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