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QA Validation Product & Process Specialist (H/F/X)

June 9th 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 modeling, through GMP manufacturing, process development, quality services, Catalent’s teams are fully committed to helping their clients fulfill their objective of providing sustainable and affordable therapies to their patients.

Mission Description

 

  • The QA Validation Product & Process is responsible to implement and maintain the validation system aspects.
  • The QA Validation Product & Process is responsible to implement and maintain the following quality systems. He/She :
  • Takes in charge of all Product & Process Validation aspects in this subjects related matters in the Catalent organization.
  • Takes in charge of all Validation aspects for the analytical QC methods (new and transfers) in this subjects related matters in the Catalent organization.
  • Updates the SOPs linked with Product & Process Validation and analytical QC methods aspect and maintaining the validated status.
  • Provides QA validation support for the change control process to ensure that execution complies with internal policies and procedures for the aspects for which is he/she responsible.
  • Ensures the review, challenge and approval, in compliance with GMP, Deviation, CAPA, Change Control, Risk Analysis quality system documents.
  • Reviews and approves the protocols and reports liked with the Process Validation and Analytical methods validation to give the assurance they are compliance with the current regulation.
  • Updates and take appropriate measures to control the risks associated for the aspects for which is he/she responsible.
  • Be the Subject Matter Expert covering QA questions, related to Product & Process Validation and Analytical methods validation aspects, by customers or internal teams.

Candidate profile

  • Expert in GMP environment
  • Good knowledge of quality tools ( cGMP, Well acquainted with Change control/ deviation and market compliance management system)
  • Experience of minimum 3-5 years in Quality Assurance, preferably in a  bio-pharmaceutical company and with Analytical method validation.
  • Fluency in French and good speaking, reading comprehension and writing skills in English
  • Good communication skills
  • Rigorous, conscientious, flexible and honest, Quality mind, Ownership
  • Willing to bring new challenges

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