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QA admin assistant (H/F/X)

April 13th 2021

Based in Gosselies, the mission of Catalent Cell and Gene Therapy is to deliver optimized process industrialization capacities to cell therapy organizations, and speed up the arrival of their therapies onto the market. From technology selection to business modelling, through GMP manufacturing, process development, quality services, Catalent’s teams are fully committed to helping their clients fulfil their objective of providing sustainable and affordable therapies to their patients.

Mission Description

The QA Admin assistant is an active member of QA System Department and will ensure the maintenance of the Quality Management system and focus in the maintenance of the following system :

  • Collect file for audit preparation.
  • Archive audit reports
  • Archiving batch records and its annexes.
  • Maintain the organization of the scanned documents.
  • Sent scanned documents to the customers.
  • Communicate the date effectivity of the GMP documents.
  • Update the Key Indicators Performance related to the QA department.
  • Update and follow up deviation, Out Of Spec, risk assessment, CAPA, change control, change request form, change notification, procedures, suppliers and sub-contractors data bases.
  • Maintain the data base and personal documents up-to-date.
  • Maintain the documentation module up-to-date.
  • Feeds and supports initiatives in Environment Health and Safety protecting life and well being
  • provide a full scanning and photocopying service as part of the Quality Systems Team
  • provide an efficient administration service to the Quality Department. This may include such tasks as scanning, reconciliation, filing, archiving and retrieval, ordering stationery.
  • Collect data and create Metrics for periodic Management review and AQR to measure the results and efficiency of the QMS.
  • Manages requests for access to the various quality systems management tools

Candidate profile

  • Bachelor degree or equivalent by experience
  • Experienced in GMP environment
  • Problem solving capabilities
  • Good command of both French and English
  • Details oriented

Offer

  • Full-time position (40h/week).
  • An indeterminate contract.
  • The opportunity to take part in a growing dynamic biotech company.
  • A human-sized working environment with a convivial atmosphere

Contact Details

To apply for this job, please send your application on the following link : Catalent