QA Validation Manager
il y a 2 semaines
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 Validation Manager.**
**The Role**
The QA Validation Manager is responsible to implement and maintain the Validation system aspects and the following quality systems
- Manages and leads the implementation of a validation system for the different sites of the Catalent Gosselies Campus
- Lead the implementation on general Catalent requirement in local documentation. (In place and in use)
- Manage the routine activities with the team QA Validation (Shopfloor, Oversight, Qualification/Validation activities,... )
- Lead the validation quality aspect for the Catalent Gosselies Campus projects (area modification, process implementation,...)
- Prepares the transition to routine engineering activities after major site projects with the support of the QA Engineering team.
- Provides QA Validation support of change control process to ensure execution are compliant with internal policies and procedures for Validation aspects.
- Is a Subject Matter expert on Quality Validation aspect by customers, authorities or internal teams.
- Ensures the review, challenge and approval, in compliance with GMP, Deviation, CAPA, Change Control, Risk Analysis quality system documents.
- Reviews and approves the protocols and reports to give the assurance they are compliance with the current regulation.
- Updates and takes appropriate measures to control the risks associated with Qualification & Validation process.
- Manage and Follow Key Performance Indicators in place.
- Expert in GMP environment
- Good knowledge of quality tools ( cGMP, Well acquainted with Change control/ deviation and market compliance management system)
- Experience of minimum 10-15 years in Quality Assurance, pharmaceutical company.
- Good communication skills
- Rigorous, conscientious, flexible and honest, Quality mind, Ownership
- Willing to bring new challenges
- Fluency in French and good speaking, reading comprehension and writing skills in English
- Experience in a biopharmaceutical company and knowledge of quality tools is a must
**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
**Position Benefits**
- The opportunity to take part in a growing dynamic biotech company
- A human-sized working environment with a convivial atmosphere
- Full-time position (40h/week), with 12 days recuperation time
- An indeterminate contract
- Company car, fuel card
- Health & Group insurance, meal vouchers, eco-vouchers
**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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