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Supplier Quality Assurance Specialist (M/F)

January 11th 2021

Based in Gosselies, the mission of Catalent Gosselies 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 Gosselies’s teams are fully committed to helping their clients fulfil their objective of providing sustainable and affordable therapies to their patients.

Mission Description

Reporting to his/her QA Manager, the purpose of this role is to provide quality support to strengthen the following topics:

  • qualification, maintenance and monitoring of Catalent Gosselies’ GxP suppliers.
  • emphasis on continuous improvement, risk management and supply chain reliability
  • interaction with GxP Supplier Quality Management at a local (Gosselies Site) and a Corporate (multiple sites of Catalent) level
  • This role will also manage and be responsible for QA oversight of outsourced GXP and Human Body Material activities (HBM).

This job requires working closely with quality control, logistics, field operations, other quality assurance departments and Catalent Gosselies suppliers to identify and manage the needs of each stakeholder.

The purpose of the function is to make a significant contribution to ensuring compliance with product requirements and associated process controls.

Key responsibilities will include, but may not be limited to:

  • Support company’s activities with risk assessments, qualification, monitoring and development of suppliers
  • Schedule and perform system, product, and process audits of suppliers to assist in developing suppliers and assuring continual improvement.
  • Store, evaluate and monitor contract performance to ensure compliance with contractual obligations and to determine need for changes/renewals etc.
  • Drive supplier improvement initiatives including Supplier Corrective Action (CAPA)
  • Initiate investigate and document complaints and incidents linked to third parties of the company.
  • Support the internal audits program & customers and regulatory audits (AFMPS, FDA…)
  • Establish the Quality & Technical Agreements and appropriate Quality Contracts with third parties
  • Manage the Approved Suppliers List
  • Lead the risk assessments of the suppliers
  • Maintain the Quality Assurance documents linked to his/her department, the Intermediate Structure and the Biobank (ie: QMS’ documents, Deviations, change request/control)

Candidate profile

  • Minimum years of relevant work experience: 1-3 years’ experience in manufacturing environment
  • Master’s Degree in life Sciences
  • Strong Microsoft Excel skills
  • English level B2
  • Knowledge of Quality Systems and supporting documentation
  • Knowledge of GMP standards (EU and US): 21CFR, Eudralex, ...

Soft skills    

  • Rigorous, conscientious and honest
  • Ability to adapt and demonstrate flexibility in dealing with changing priorities and work situations
  • Analytical critical mind & quality mindset
  • Autonomous and organized (good time management skills)
  • Strong interpersonal, verbal and written communication skills to communicate clearly with manufacturing, purchasing, engineering, and supplier/vendor personnel

Catalent’s standard leadership competencies that are used to interview and for Performance & Development:

  • Delivers Results
  • Leads with Integrity and Respect
  • Demonstrates Business Acumen
  • Fosters Collaboration and Teamwork
  • Champions Change
  • Engages and Inspires
  • Coaches and Develops

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