QA Systems

Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in providing development, production and packaging services for pharmaceutical and biotech companies.

For our sterile production site located in Belgium in Brussels (Neder-Over-Heembeek), we are currently looking for a** **QA Systems & Compliance Specialist**.

As part of this function, the QA System & Compliance Specialist will ensure appropriate level of compliance for processes such as Change Control, Annual Product review, CPV (Continued process Verification) and Continuous improvement projects. They are also in charge of site quality metrics, responsible for implementing and closing assigned QMS actions, and the implementation for updated or new corporate policy at site level.

**The Role**
- Compile and encode different data sets related to Catalent products, analyse and interpret the results in order to write Annual Product Reviews (APR) and Continued Process Verifications (CPV).
- Acts as primary lead for TrackWise to optimize & administrate Quality System Database TrackWise (user management and support; follow-up of system upgrades).
- Coordinate CAPA and change actions closures and follow-up with relevant departments(documenting QA decisions).
- Review and follow up of Change Controls and Risk assessments for the Brussels Site.
- Support on Quality Management Review Preparation.
- Perform the alignment check of the local SOP as per corporate policy update
- Participate in Quality Oversight of the operational department by executing of shop-floor spot-checks or as a qualified auditor to execute internal audits.
- Ensure Data Integrity for all activities performed.
- University degree, preferably scientific degree such as Pharmacist, Bio-Engineer, Chemistry, biology, or equivalent.
- 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.
- 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 offer 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.

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.