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The Company

For a Global Pharmaceutical company based in Walloon Brabant a Regulatory Affairs Specialist is needed to assist the RA&QA departments. The company utilises the latest technology to develop, manufacture and sell therapeutically active ingredients. 

Role Description

As a Regulatory Affairs Specialist you will have a combination of RA & QA duties.Continually contributing to the sites Quality Management & Regulatory processes.This includes but not limited to: Ensuring timely submissions to Health Authorities. Assist Sales & Marketing in promoting and give potential and current customers the highest possible quality service. Manage and approve change controls, CAPAs & deviations.

 

Responsibilities

  • Maintain registrations in compliance with the procedures in place and with the current regulatory regulations
  • Be the direct contact with customer’s and regulatory authorities
  • Compile registration applications
  • Develop, implement and manage documents related to Quality Operations
  • Assure the release of API batches
  • Develop, implement and manage documents related to Quality Operations
  • Perform internal audits as required

 

Requirements

  • MSc. Pharmacy / Industrial Pharmacy / Bio-Eng./ Ind. Eng.
  • Min. 5 years of experience within API manufacturing 
  • Excellent working knowledge of EU RA, GMP & ISO 9001
  • Excellent command of Microsoft Office
  • Previous experience working in cross functional teams
  • You speak & write fluent French and English

 

Other information

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