JOBS

Back

QA System Specialist (M/F)

January 11th 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. To lead its increasing number of development and manufacturing projects, Catalent Cell and Gene Therapy is looking for a highly motivated QA System Specialist.

Mission Description

The QA System Specialist (audit expert) will ensure the maintenance and the improvement of the Quality Management system and the compliance with applicable US/EU regulations, guidances and Catalent’s policies/procedures.

In life cycle phase, the QA System Specialist  is focus in the maintenance of the following system :

  • Update, in compliance with the current regulation the QA quality system documents.
  • With the collaboration of concerned department, establish annually the Annual Quality Review (AQR)
  • Review, challenge and approve, in compliance with GMP, Deviation, CAPA, Complains, Audits, Change Control, Risk
  • Update, analyze the process of deviation, capa, change control, risk analysis with KPI. Propose and realize adapted action.
  • Ensure the internal audit program is compliant to current regulations as required. Plan, coordinate (scheduling, and reporting) and perform audits of the plant systems and procedures.Update and take adapted action to ensure the CAPA follow up
  • Update and realise the Self Inspection quality system documents and take adapted action to ensure the CAPA follow up
  • Quality Risk Management

Candidate profile

The Candidate

  • Master degree or Bachelor degree in biology, pharmacy, clinical chemistry, etc., or relevant experience in a similar position in the sector of biotech/Pharma/cell therapy.
  • Fluency in French and English is a must
  • Good knowledge of cGMP and audits,
  • Experience of minimum 2-3 years in Quality Assurance, preferably in a  biopharmaceutical company
  • Microsoft office ( Word, Excel, Power Point) , TrackWise and  ComplianceWire

Soft skills     

  • Rigourous, consciencious, flexible and honest
  • Critical mind
  • Autonomous and organized (good time management skills)
  • Efficient communicator, quality minded and customer oriented
  • Quality mindset

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