Quality Systems Officer Utilities

We are looking for a **QA Systems Officer **to join us in our **QA Systems & Continuous Improvement Team **team, based in our UCB Campus office in Braine-l'Alleud, Walloon Brabant, Belgium. **About the role**: - You promote Quality and Operational Excellence and cultivate "Quality Culture", "Compliance Awareness", "Continuous Improvement Attitude" & "Accountability Culture" across the UCB teams. - You drive Quality Leadership on Quality & Compliance Strategy and interact with other functional areas to effectively communicate system & process requirements. - You are maintaining and continuously improving the Quality Management System and related processes. - You ensure continued compliance of the QMS to applicable regulations and guidelines, UCB Corporate Policies & Procedures, UCB objectives, plans and projects. **Who you'll work with**: You we be a part of the Quality Assurance department within the Quality Systems & Continuous Improvements team organization and will be in cooperation with Braine Technical Operations (BTO) and related supporting services **What you'll do**: - Using a Risk Based Approach, ensure that all Utilities, HVAC & Cleanroom Systems used by Braine Technical Operations and related supporting services are compliant with applicable regulations and guidelines (EMEA, FDA, PIC/S, ICH, best practices as defined by relevant organizations) and UCB Corporate Policies & Procedures. - Cultivate a "Compliance Awareness Culture" across the BTO department and related supporting services. - Ensure communication of compliance status and issues to the appropriate levels of the organization - Ensure a relevant cGMP level regarding subcontractors used to support routine operations for BMO and its supporting services. - Participate in the preparation for regulatory inspections and provide direct support to System Owners and main customers during inspections. - Support the System Owners to develop and implement technically robust and compliant Systems allowing to continuously improve their operations. - Responsible for all cGMP aspects related to the Utilities, HVAC & Cleanroom Systems owned by the System Owner. - Drive quality leadership and technical expertise on Utilities, HVAC & Cleanroom Systems compliance strategy and interact with other functional areas to effectively communicate System requirements. - Encourage and assist in the development of remediation and mitigation plans for Utilities, HVAC & Cleanroom Systems & Projects to ensure that they meet policies, procedures, and regulatory requirements. - Establish and/or assist in the establishment of policies, procedures and standards for UCB consistent with pertinent government regulations and procedures. - Assure that the Utilities, HVAC and Cleanrooms operate in accordance with UCB Quality Standards and applicable national and/or international regulations and guidelines (EMEA, FDA, PIC/S, ICH) - Together with the Utilities, HVAC & Cleanroom System Owners, ensure direct follow of Compliance Audit activities, Deviations, Planned Deviations, Failure Investigations and Change Control related to the Utilities, HVAC & Cleanroom Systems - Ensure cGMP training related to Utilities, HVAC & Cleanroom activities - Ensure follow-up and communication to QA Manufacturing teams of Deviations, Planned Deviations and Change Control related to Utilities, HVAC & Cleanrooms that could have an impact on manufactured batches - Support the Qualification & Validation activities for Utilities, HVAC & Cleanrooms and perform QA approval and QA authorization of related documentation. - Participation to the digitalization improvement program **Profil**: - You have a master's degree in engineering or sciences preferred - You are experienced in a regulated pharmaceutical environment or other life science or health related field is mandatory - You have experience with Quality Management Systems and Auditing is an asset - You are fluent in French and have a very good level in English - You have an affinity for Quality & Compliance and worldwide regulations pertaining to cGMP regulations pertaining to Pharmaceuticals & Medical Devices - You can balance multiple priorities - You are a fact-based decision maker with accountability - You are a team player with good interpersonal relationship and communication skills - You have good oral and written communication skills - You are capable of independently identifying problem situations and initiating problem solving