Help us transform patients’ lives! At UCB, we put our heart, soul and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend talents to unlock innovation. Will you join us in our pioneering adventure?
To strengthen our Quality Assurance team, based in our Braine site in Braine-l’Alleud, we are currently seeking a Nature and Scope of the role: Assure that all technical operations related to the production and analysis of pharmaceutical products comply with applicable regulations and guidelines (EMEA, FDA, PIC/S, ICH) and UCB corporate policies and procedures; (co-)develop and (co-)implement technical robust and compliant systems allowing to exploit, maintain, monitor and continuously improve operations; pro-actively identify, develop and implement quality improvements in response to business requirements, technical changes and regulatory requirements; Drive continuous improvement projects that will allow risk reduction, improved Quality KPI and product quality. Major Accountabilities: QUALITY MANAGEMENT SYSTEM (QMS) & AUDIT MANAGEMENT (INTERNAL AND EXTERNAL AUDITS & INSPECTIONS) Ensuring continued compliance of the QMS to applicable regulations and guidelines, UCB Corporate Policies & Procedures, UCB objectives, plans and projects Driving quality leadership and technical expertise on Quality Management System compliance strategy and interacting with other functional areas to effectively communicate Quality Management System requirements. Supporting Global QA & (Senior) Management in establishing, implementing, maintaining and ensuring continuous improvement of an effective and efficient Quality Management System (serving both local & global needs). Implementing and maintaining an adequate QS Cockpit, KPIs trending and communicating results to appropriate levels of the organization Planning, assuring execution and follow-up of internal audits to ensure compliance with internal standards and worldwide regulatory requirements with respect to GMP Lead and participate in numerous continuous improvement actions and initiatives Organizing and coordinating the preparation and the hosting of external audits, hereby acting as a major liaison forthe auditors Coordinating with appropriate management the composition of the response package to the external audit observations, ensuring timely response and assure execution of defined CAPAs and engagement Organize and assure execution of suppliers qualification process for consumables, services and equipment.
Desired experience: Minimum 4 years in a regulated pharmaceutical environment or other life science or health oriented field. Experience in Quality Assurance or internal & external auditing. Good knowledge of worldwide regulations pertaining to cGMP and Quality Management System requirements; Project-management skills; Excellent oral and written communication skills; Fluent in French and in English; Ability to lead (small) project teams and to motivate and inspire internal customers; Ability to plan and direct the actions of a group of profess... Please refer to StepStone in your application
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