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QA Training Officer (h/f)

Réf 1254828

Actualisé le 25 août 2020 par CATALENT

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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 QA Training Officer.

The QA Training Officer reports to the QA Training Manager and is responsible to: Identify individual and company trainings need; Produce Training Materials and develop a schedule to deliver trainings and related trainings tracking:  update QA trainings following cGMPs and company policies;  Deliver QA trainings as per training schedule, including basic GMP /GDP and the GMP/Good Documentation Practices annual refresher trainings Review and challenge, the training qualification reports when requested by the customers; Record the training data ; Review, challenge and approve, in compliance with GMP, Deviation, CAPA, Change Control, Risk Analysis quality system documents related to the training system; Ensure teamwork with LLSPOC to follow-up and communicate Training KPI; Communicate and escalate Training KPI for QA department, GMP departments to the Training Manager. Teamwork to design, deliver and assess training programs, review and modify training Materials when needed for the successful delivery of the trainings; Develop a schedule to assess and review current company training material for improvement; Self-Inspection: audit training delivery practices, material and related records to company training policies and procedures; Maintain company training records and datas within company LMS (Learning Management System); Review and release individuals¿ qualifications dossiers, E.g.: Aseptic Practices Simulation (APS), protocols, gowning protocols, visual inspections protocols; Annual Quality Review: (AQR) Teamwork with concerned department, to establish, review and approve the annually review; Participate to meeting related to QA Training team, Training LLSPOC network or work teams for training topics.
  • Etudes, recherche et développement / Etudes en sciences économiques, sociales et humaines

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Mr Belgium Stepstone
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