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Quality Assurance Senior Specialist - Belgium  

Company managed [?] Still accepting applications

Posted on : 01 December 2016

Project Description

In order to face the development of our activities, we are currently seeking a Quality Assurance Senior Specialist to support the Quality Assurance/Regulatory Affairs activities related to the development of new technology based allergy immunotherapy products.

Main responsibilities will include: 

  • Establish policies, procedures and quality standards (working with operating staff to establish technical procedures)  
  • Assure compliance with quality and industry regulatory requirements 
  • Organize in-process control and ensure proper documentation is in place 
  • Develop and monitor quality indicators 
  • Organize,  execute  and  document  internal  audits  and develop,  recommend  and monitor appropriate corrective actions  
  • Coordinate  and  support  on-site  audits/inspection  and perform  audit  of subcontractors 
  • Determine training needs and establish training plan 
  • Review  and  approve the batch  records of  R&D department as  well  as  study reports that  will  be  incorporated  into  regulatory  submissions  to  assure  scientific  rigor  and accuracy 
  • Release  the  batches  of  drug  substance manufactured  by  contract  manufacturing organizations and ensure the timely release of the batches of drug product 
  • Coordinate  investigations  required  following  deviation  and out-of-specification results 
  • Is responsible for document management systems 

Requirements and competencies 

Scientific degree in life sciences or pharmacy 
Minimum 5 years of experience in the field of Quality Assurance 
Aptitude for problem analysis and solving 
Attention to detail 
Decision making 
Acting as a catalyst for change and improvement in performance/quality 
Team player, strong interpersonal skills 
Strong organizational and communication skills (oral and written) 
Fluent French and English 
Demonstrated ability to deliver results to the appropriate quality and timeline


We offer  

A company with a very high growth potential, Interactions with a very competent team and motivating environment, Involvement in the development of innovative products to satisfy a real unmet medical need, Attractive salary and benefit package 


About Us

We are a  Belgian  clinical  stage  biopharmaceutical  company  focused  on  the development  and  future  commercialisation  of  a  range  of  breakthrough  immunotherapy products  for  the  treatment  of  allergies.  We have a headcount of 22 staff members, located at our headquarters and in the laboratory.