Qc Microbiology Technician

il y a 2 semaines


Gosselies, Belgique Catalent Temps plein

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 modelling, 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 QC Microbiology Technician.

**The Role**:
The QC Microbiology Technician main role is to perform all administrative and laboratory activities inside the QC Microbiology Platform.

The responsibilities can be adapted and may cover the following topics (EMS, Equipment, Lab Management, Cleaning, ) to support the start of our commercial facility with a GMP quality grade and in an efficient way.

The QC Microbiology Technician reports to the QC Microbiology Supervisor.

In order to fulfill his / her role, he / she:

- Performs his/her duties and document his/her work according to Catalent’s current procedures and GMP rules.
- Performs QC tasks in due time according to the planning and in compliance with effective instructions / procedures and all laboratory / safety procedures.
- Performs on due time routine and planned maintenance, calibration of equipment in the QC Department.
- Performs the samples shipment (outsourcing) for the QC department.
- Performs routine Microbiological testing when needed (Environmental Monitoring samples, Growth promotion tests,).
- Warns immediately the Supervisor or Manager in case of unusual event / result / OOS.
- Double checks filled forms or data generated for testing which he / she is trained.
- Initiates or reviews DEV, OOS, CHC linked to the Microbiology Platform and leads necessary investigation. Implement CAPA.
- Participates in troubleshooting of experiment and equipment issues.
- Performs the management of routine QC Reagents stock level.
- Order the adequate material, reagents, consumables and ensures its availability in due time in QC laboratories.
- Request the picking of the incoming material reference samples and assure their storage in the appropriate conditions.
- Performs the maintenance of the laboratory (bench and floor cleaning, waste evacuation, general aspect )
- Drafts QC documents (INS, PRO, FORM, GSPE).
- Follows the needed training on due time.
- Maintains open, effective, constructive and positive communication with all other QC members and with other departments.
- Warns immediately the QC Expert /Supervisor or Manager in case of problem or failure or security issue.
- Participates actively to the weekly QC meeting.
- Works to keep department KPI in green.
- Takes part to internal and/or external audits, if necessary
- Bachelor degree.
- Experience in cGMP environment and/or quality control is a must.
- Organization skills, multitasking, flexibility and autonomous.
- Teamwork
- Results oriented; problem solving.
- Quality minded, rigorous and pro-active.
- Fluent in French
- English at least A2 level
- Computer skills: Microsoft Office, Compliance Wire, TrackWise are a plus.

**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**
- 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.
**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 procéd


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