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QC TRAINING SR EXPERT (H/F/X) (h/f)

Réf 1382239

Actualisé le 23 février 2021 par MASTHERCELL

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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 QC Training Sr expert.
 
The Role
The QC Sr expert - training main role is to implement QC training strategy and maintain the training system the in the Quality Control department.
He reports to the QC supervisor QC services. In order to fulfill his role, he:
Identifies individual and departemental training needs.Is the LLSPOC (QC representative for training and training management for QC department).Drafts and gives training associated to generic activities in compliance with cGMP and company quality system.Manages and reviews the training qualification of visual inspection of prod and QC operators.Reviews the training records of the QC departement.Is responsible to maintain QC Training KPI in green.Develops a schedule to deliver trainings within the QC departement.Reviews QC documents linked to training.Takes the lead and reviews deviations/CAPA, Change Control, Risk Analysis quality system documents related to the training system.Takes part to internal and/or external audits, if necessary.Maintains an open and effective communication with all other QC team members and with other departments.
In addition of these activities, the current challenges of the position are:
Rearrangement of training system from a projects organisation to a platform organisation with dedicated analytical methods.Decrease the time needed to make the operators operationals.
In addition, the QC supervisor will support the QA with the general improvement of the quality system linked to training as part of the commercial readiness program.
 
The Candidate
Qualifications & Experience
At least Bachelor level in chemistry, biochemistry, clinical chemistry, biology, etc.At least 5 years' experience in cGMP or experience in a similar position.English level: at least B1.Computer skills: Microsoft office, ComplianceWire, Documentum, TrackWise are a plus.
 
Skills & Competencies
Organization skills, multitasking.Quality minded, autonomous, rigorous, attentive to details, persevering and pro-active.Teamwork and teaching skills.Good communication skills and cheerful.
 
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.

Profil

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Connaissances linguistiques

Français : Bon
Anglais : Moyen
  • Gestion d'entreprises, de services et de projet / Gestion de services

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