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Quality Systems Improvement Project Associate - Belgium  

Keyrus Biopharma (company)


Posted on : 15 April 2017

Project Description

Job Description
We are looking for an experienced Quality Systems Improvement Program Associate for one of our clients.

Role and main tasks
The candidate will :  
  • Implement the Global Quality Manual in one of the company's site
  • Compare the site's practices with the updated global guidelines:
    • Establish gaps - make an implementation plan per segment, with deadlines for making modifications and process adaptations
    • Establish matches - update site Quality Manual if needed
  • Follow-up with managers and global experts to fix gaps for further implementation
  • Maintain deadlines and extend them in certain cases, which ask more time implement the new way of working
  • Investigate the impact of modifications on the organization
  • Give trainings internally on the new way of working
  • Have contact with global experts regularly (WebEx based)  

  • Scientific background  

Required skills: 
  • Wide experience in and passion for quality management systems is a must
  • Good knowledge of GMP (Good Manufacturing Practices)
  • ideally, at least 3 years in the pharmaceutical industry
  • Mature and decisive personality
  • Good organizational skills
  • Fluent in Dutch and English
  • Will travel once in a while to others plants in Europe to follow joint training on new requirements, but flexible timings and respect for work/life balance  

What We 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 project management, clinical monitoring, scientific and medical support, site management, biostatistics, data management, product safety, quality assurance, regulatory affairs, and medical writing.