Document / Training Compliance Associate
Ablynx
Ghent, Belgium
7 dagen geleden

Purpose of the Position :

Be part of the quality department responsible for supporting the document, sample, training management and archiving in compliance with the GxP and R&D requirements.

Key Responsibilities :

  • In the role of Document Manager You make the active Controlled Quality Documents available for AblynxYou move the obsolete Controlled Quality Documents to the archiveYou manage the document coding of the Controlled Quality DocumentsYou follow-
  • up on the periodic review of the Controlled Quality DocumentsYou are responsible for the document management system and provide training on request You support QA Lead during inspections from external organizations

  • In the role of Archivist You archive documents and samples conform the GxP requirementsYou manage the archive conform the specific procedures
  • Training Manager You manage the training systemYou are responsible for maintaining the training records up to date for the GxP environment
  • Publisher You maintain the templates of reports up to date and centrally availableYou perform an eCTD compliance screening on eCTD compliant documents
  • All-round administrative support You treat the shipments : you complete and follow up all the necessary documents and procedures in a correct and timely manner.
  • Skills, expertise and contribution :

  • Administrative consciousness and correctness
  • Organizational skills : good organization skills to be able to follow-up documentation and actions related to multiple audits
  • Team player, good communication and negotiation skills, proactive
  • Sense for initiative, quality, accuracy and detail
  • Knowledge of Dutch and good writing / reading skills in English
  • Minimum Qualifications :

  • Expected educational qualifications : at least a Bachelor degree
  • Expected experience : 2-3 years experience in a Quality department, preferably in the biotechnology domain
  • MS Office : Very good
  • Very good knowledge of English
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