QA Sterility Assurance Leader
il y a 2 semaines
**Position Summary**
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 Sterility Assurance Leader.
**The Role**
The QA Sterility Assurance Leader is responsible to implement the Sterility Assurance system aspects and will be an active member of QA Validation and Sterility Assurance team.
The QA Sterility Assurance Leader is responsible to maintain the following quality systems:
- Implement all Sterility assurance aspects in the Catalent Gosselies organization.
- Lead the implementation on general Catalent requirement in local documentation. (In place and in use)
- Expert in the sterility assurance aspect for all process changes, new processes, implication in validation strategies, requalification,...
- Provides QA Validation support of change control process to ensure execution are compliant with internal policies and procedures for Sterility Assurance aspects.
- Ensures the review, challenge and approval, in compliance with GMP, Deviation, CAPA, Change Control, Risk Analysis quality system documents.
- Expert for protocols and reports liked with the Sterility assurance emitted to give the assurance they are compliance with the current regulation. (Environmental Monitoring, Media Simulation process)
- Expert in GMP environment
- Good knowledge of quality tools ( cGMP, Well acquainted with Change control/ deviation and market compliance management system)
- Experience of minimum 5 years in Sterility 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 command of English
- Experience in a biopharmaceutical company and knowledge of quality tools is a must
**Position Benefits**
- Full-time position (40h/week).
- An indeterminate contract.
- The opportunity to take part in a growing dynamic biotech company.
- A human-sized working environment with a convivial atmosphere.
- Health and group insurance
- 20 legal vacations days and 12 days recuperation time
- Company Car
**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.
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