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QC Expert Outsourcing (H/F/X)

June 23rd 2021

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.

Mission Description

The Role

The QC Expert outsourcing main role is to organize the outsourcing activities linked to QC. These activities are divided in these different fields:

Single point of contact for the QC subcontractors for quotation, analytical set up discussion, instructions approval, double check of raw data, review of the COA of the outsourcing lab
Management of the planning of the outsourcing activities and follow up. Optimizes the lead time from shipment to result.
Plans and organises shipments in collaboration with technical services
Is responsible of the documentation associated with the shipment
Ensure dev/CAPA/OOS are written on due time, and is reviewer regarding outsourcing activities
Follows EP regulatory updates and assess the impact on current outsourcing  processes
Takes part to internal and/or external audits, if necessary;
Maintains open and effective communication with all other QC team members and with other departments (Production, QA, and Technical Service).
In addition to these activities, the current challenges of the position are:

Set up of a central outsourcing activity within the QC departement, in place of a project based outsourcing activity

Candidate profile

The Candidate

Qualifications & Experience

At least Master level in chemistry, biochemistry, clinical chemistry, biology, etc.
At least 2 year’s experiences in cGMP environment.
At least B1 English level - fluent in French
Ability to challenge a test based on a procedure without performing it
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.
Computer skills: Microsoft Office, Ms Teams
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

Offer

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.

Contact Details

To apply for this job, please send your application on the following link : catalent