QA System Specialist
il y a 2 semaines
**Position Summary**
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.
To lead its increasing number of development and manufacturing projects, Catalent Cell and Gene Therapy is looking for a highly motivated **QA Systems Specialist**.
**The Role**
The QA System Specialist will ensure the maintenance and the improvement of the Quality Management system and the compliance with applicable US/EU regulations, guidance’s and Catalent Gosselies procedures.
The QA System Specialist is an active member of QA System Department and will be accountable as Subject Matter Expert, providing guidance for the following systems:
- Document management
- Audits
- CAPA
- Deviations
- Change control
- Risk assessment
In life cycle phase, the QA System Specialist focuses on the maintenance of the following systems:
- Pharmaceutical Quality 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), the Management Review.
- Review, challenge and approve, in compliance with GMP, Deviation, CAPA, Complains, Audits, Change Control, Risk
- Update, analyse 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.
- Self-Inspection: Update and realise the Self Inspection quality system documents and take adapted action to ensure the CAPA follow up
- 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.
- Experience of minimum 3-4 years in Quality Assurance, preferably in a biopharmaceutical company
- Experience in cGMP audits; Experience in cell therapy is a real plus
- Good knowledge of cGMP
- Critical mind, Ownership, Autonomous and organized (good time management skills)
- Efficient communicator, quality minded and customer oriented
- Fluency in French and English is a must. Must be able to read and understand English-written job instructions and safety requirements
- Computer skills: Microsoft office ( Word, Excel, Power Point), Track Wise and Compliance Wire
**Position Benefits**
- Full-time position (40h/week)
- An indeterminate contract
- Group & Health Insurance
- Meal vouchers & Eco-vouchers
- The opportunity to take part in a growing dynamic biotech company
- A human-sized working environment with a convivial atmosphere
**Catalent offre des opportunités enrichissantes pour faire avancer votre carrière** Rejoignez le leader mondial du développement et de la production de médicaments et aidez-nous à proposer plus de 7 000 produits qui sauvent et améliorent la vie des patients du monde entier. Catalent est une société internationale passionnante et en pleine croissance où les employés travaillent directement avec des sociétés pharmaceutiques, biopharmaceutiques et de santé grand public de toutes tailles pour faire progresser de nouveaux médicaments, du développement précoce aux essais cliniques et à la mise sur le marché. Catalent produit plus de 70 milliards de doses par an, et chacune sera utilisée par quelqu'un qui compte sur nous. Rejoignez-nous pour faire la différence.
Catalent s'engage à protéger la santé et la sécurité de ses employés, de ses visiteurs et des clients et patients que nous servons. À la suite de la pandémie mondiale, nous avons modifié bon nombre de nos processus de recrutement et d'intégration pour assurer la sécurité de tous. Les équipes des ressources humaines communiqueront tous les processus et procédures de sécurité nécessaires à chaque étape.
Initiative personnelle. Rythme dynamique. Un travail significatif.
Visitez Catalent Careers pour explorer les opportunités de carrière.
Catalent est un employeur garantissant l'égalité des chances et ne fait aucune discrimination sur la base d'une caractéristique protégée par la législation locale.
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