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Quality Officer - Belgium, Netherlands  

Company managed [?] Still accepting applications

Posted on : 09 May 2017

Project Description

Description:
 The Quality Auditor/officer conducts routine audits of data, information, procedures, equipment and systems (including computer systems), and/or facilities to ensure the compliance with SOP's and GMP's and worldwide regulations.  
  • Review and approve production and analytical documentation accompanying the release of API, Safety Assessment or clinical supply lots (bulk and packaged) to ensure conformance to appropriate regulatory requirements.
  • In addition, the Auditor communicates and resolves audit comments with client areas.
  • Under supervision, or as part of a team, perform audits or inspections of assigned areas or systems to assess compliance with regulatory and Company standards.
  • Issue reports summarizing deficiencies and work with areas to execute remedial action.
  • Notify appropriate management of inspection result.
  • Position will receive direction and support.  



Requirements:
  • Bachelor's or Master's Degree in Science or Engineering with at least 5 years of experience in the pharmaceutical industry within the Quality Operations Department
  • Minimum of 3 years of experience with exposure to investigations execution in an FDA related environment with technical expertise and strong Quality Systems background
  • Knowledgeable with cGMP's applied to drug product/drug substance and manufacturing is required
  • Technical knowledge in manufacturing processes and analytical testing techniques
  • Effective planning skills
  • Excellent interpersonal and communication (oral and written) skills, in English
  • Technical Writing
  • Root Cause Analysis
  • Failure Mode & Effect Analysis (FMEA)
  • CAPA establishment and Lean Six Sigma
  • Experience with documentation systems and SAP is a preference  




Offer:
  • A young and dynamic company with a feel good culture, an a great openness and a no-nonsense approach
  • Real investment in people through education and fun events
  • A competence development model focused on your personal ambitions
  • An attractive salary package