QA Systems

As part of this function, the QA System & Compliance Expert will provide support during internal audits, customer audits and regulatory inspections, as well as during new product introduction projects.Additionally, the QA System & Compliance Expert will act as back-up for other routine activities of the QA System & Compliance department (e.g. change control management, corrective and preventive actions and support of the Quality Management Review).

**The Role**:

- Leading the Quality Risk Management process, in cooperation with all departments from Catalent Belgium. This includes the compilation of different data sets related to different departments/products; its analysis, discussion and interaction with concerned experts.
- Execution of internal audits as well as performing associated reviews
- Preforming gap analyses towards applicable standards (internal/corporate standards as well as external regulations)
- Participate in Quality Oversight by execution of shop-floor spot-checks
- Coordinate continuous quality improvement projects.
- Act as SME for those topics during the audits and inspections hosted at the site.
- Support the Quality department for answering Client quality questions and requests.
- Act as a support for the team by doing back-up activities such as management of external audits and their preparation, change controls and CAPA, reporting activities, material management, official document handling and other supportive activities to the team objectives.
- University degree, preferably scientific degree such as Pharmacist, Engineer, or equivalent. Or equivalent by experience.
- Experience in working in a quality/GMP environment
- Fluent in French and English, Dutch is a plus
- Positive energy and mind-set
- Excellent communication skills
- Team player, integrity
- Accountability for results and persistency
- Stress resistance, analytical thinking
- Experience in Lean Project Management is a plus
**Position Benefits**:

- What we offer is an exciting role, a chance to grow and learn new skills in a global company, and in the most challenging quality environment within the pharma industry - a sterile business
- Potential for personal development within an international company
- Defined career path and annual performance review and feedback process
- Contributory pension and benefits package all offered from day one of employment
- 36 days’ holiday + bank holidays
**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.