Quality Investigation

Manage the investigation activities for critical/major deviations and quality events, evaluating the types of intervention together with Quality Assurance and other local and international Roles, internal and external to the site, including customers.

Verify the execution of corrective/preventive actions and monitor their effects to assess whether the causes of the deviations have been correctly identified.

**The Role**
- Be the point of reference for the management of investigations following critical/major deviations and quality events
- Study and propose investigative methods in compliance with GMP directives/regulations and Catalent policies, while respecting customer expectations
- Evaluate together with the SMEs the technical and documentary feasibility of corrective/preventive actions including the EHS impact
- Interface with the client for discussion of the investigative outcomes and corrective actions identified, collecting and evaluating potential suggestions received, involving cross-functional teams where necessary
- Share the investigative results, the actions undertaken/planned with the various managers and with the Management Team
- Be the point of reference within your own role and support the other roles for investigations, including through review and/or training/training on the job/feedback activities
- Plan the group's activities, identifying critical issues and indicating priorities in carrying out investigations, in accordance with cross-functional inputs (i.e. QA, Customer, Supply Chain)
- Coordinate your own resources, evaluating their performance, managing their development plans and proposing any salary improvements.
- Collaborate with the Catalent network for the sharing of best practices and alignment with corporate strategies.
- Define and evaluate the group's KPIs by identifying appropriate actions by monitoring and acting proactively and anticipating critical issues
- Active participation in audits of customers and regulatory bodies
- Degree preferably in Chemistry, CTF, Biology, Biotechnology, Chemical Engineering, Science
- Knowledge of efficiency and productivity parameters.
- Knowledge of production management processes.
- Communication, listening and mediation skills
- Knowledge of Common Investigation tools ( FMEA, 5 WHY, FISHBONE, etc)
- Ability to holistically view the investigative process and resource workloads
- Langues : English and French

**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 (health/group insurance)
- Meal Vouchers, Eco Voucher, Company Car
- 36 days’ holiday + bank holidays

**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

**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.