QA Engineering Manager
il y a 5 jours
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 Engineering Manager**.
**The Role**
The QA Engineering Manager is
- responsible to implement and maintain the Engineering oversight activities on Catalent Gosselies Buildings.
- an active member of QA Validation team.
- responsible to implement and maintain the following quality systems.
- Lead the implementation on general Catalent requirement in local documentation. (In place and in use)
- Manages and leads the implementation of a common system for the different sites of the Catalent Gosselies Campus
- Develop the simplest, most proactive and streamlined quality process for new facility startups on campus and optimize existing processes.
- Serves as the primary technical quality contact and manages the routine activities with the QA Engineering team (Shopfloor, Oversight, Requalification activities, shutdown management,... )
- With the engineering and QC support teams, ensures the maintenance of the production equipment and QC laboratories for the Campus as well as the facilities and utilities
- Prepares the transition to routine engineering activities after major site projects with the support of the QA Validation team
- Is a Subject Matter expert on Quality Engineering aspect by customers, authorities or internal teams.
- Provides QA support of change control process to ensure execution are compliant with internal policies and procedures.
- Ensures the review, challenge and approval, in compliance with GMP, Deviation, CAPA, Change Control, Risk Analysis and all other Quality System documents.
- Updates and analyses the process of preventive maintenance with KPI. Proposes and realizes adapted action.
- Updates and takes appropriate measures to control the risks associated with technical 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 years in Quality Assurance, preferably in a biopharmaceutical 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
**Position Benefits**
- Full-time position
- An indeterminate contract.
- Group & health insurance
- Meal vouchers & Eco Vouchers
- Company car
- The opportunity to take part in a growing dynamic biotech company.
- A human-sized working environment with a convivial atmosphere.
**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 aucu
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