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QA CSV Validation (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 QA CSV Validation is an member of QA Validation team.

The QA CSV Validation is responsible to implement and maintain the following quality systems in the CSV qualification activities. He/She :

Updates the Validation, Qualification Master Plan associated with the CSV activities in accordance with the QA validation equipment.
Reviews and approves the Qualification and Validation protocols and rapports emitted to give the assurance they are compliance with the current regulation for the CSV aspects. In association with the QA Validation equipment for all systems and equipment with a GAMP categorisation.
Reviews and approves the operational documentation for the projects
Participate to deployment of Data Integrity program, LSPOC DI
Ensures the review, challenge and approval, in compliance with GMP, Deviation, CAPA, Change Control, Risk Analysis quality system documents.
Updates and takes appropriate measures to control the risks associated with CSV aspects for Qualification & Validation process.

Candidate profile

The Candidate

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 Quality Assurance, preferably in a  biopharmaceutical company
Fluency in French and good speaking, reading comprehension and writing skills in English
Good communication skills
Rigorous, conscientious, flexible and honest, Quality mind, Ownership
Willing to bring new challenges
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).
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