JOBS

Back

QA Validation 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 Specialist is responsible to implement and maintain the validation system aspects.
  • The QA Validation Specialist is responsible to implement and maintain the following quality systems. He/She :
  • Supports all Qualification & Validation aspects in the project related matters in the Catalent organization.
  • Ensures the review, challenge and approval, in compliance with GMP, Deviation, CAPA, Change Control, Risk Analysis quality system documents.
  • Is a Subject Matter expert covering QA questions, related to QA Validation, by customers or internal teams.
  • Updates and takes appropriate measures to control the risks associated with Qualification & Validation process.
  • Updates the Validation, Qualification and Calibration Master Plan (site and projects).
  • Reviews and approves the Qualification and Validation protocols and rapports emitted to give the assurance they are compliance with the current regulation. In association with the QA Validation CSV for all systems and equipment with a GAMP categorisation.
  • Updates, analyzes the process of preventive maintenance with KPI. Proposes and realizes adapted action.

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
  • 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