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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. 


Responsibilities:
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)  


Profile
  • 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.
 

Locations

Brabant Walloon Belgium

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