QA Systems Officer – Utilities
il y a 6 jours
Contracting – Brabant Wallon General QA Role: Promote Quality and Operational Excellence and cultivate "Quality Culture", "Compliance Awareness", "Continuous Improvement Attitude" & "Accountability Culture" across the UCB teams. Drive Quality Leadership on Quality & Compliance Strategy and interact with other functional areas to effectively communicate system & process requirements. Maintaining and continuously improving the Quality Management System and related processes. Ensuring continued compliance of the QMS to applicable regulations and guidelines, the company Corporate Policies & Procedures, objectives, plans and projects. QA Systems Officer on Utilities, HVAC & Cleanroom Systems & Operations: Using a Risk Based Approach, ensure that all Utilities, HVAC & Cleanroom Systems used by the campus and related supporting services are compliant with applicable regulations and guidelines (EMEA, FDA, PIC/S, ICH, best practices as defined by relevant organizations) and the company Corporate Policies & Procedures. Cultivate a "Compliance Awareness Culture" across the manufacturing 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 the Braine Manufacturing site 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 the company consistent with pertinent government regulations and procedures. Assure that the Utilities, HVAC and Cleanrooms operate in accordance with the company 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. Master Degree in engineering or sciences preferred Experience in a regulated pharmaceutical environment or other life science or health related field is mandatory Fluent in French, very good level in English is required Affinity for Quality & Compliance and worldwide regulations pertaining to cGMP regulations pertaining to Pharmaceuticals & Medical Devices Team player with good interpersonal relationship and communication skills Jefferson Wells offers you a permanent cont... FDA, Pharmaceuticals, Expertise, Manufacturing Site, Documentation, Communication, Medical Devices, Health System, Compliance Audit, Engineering Science, Communication, Clean room work, Manufacturing, Validation, Mitigation, Projects, Inspection, Regulation, Development, Investigations, Pharmaceuticals, Training, Policy, Communication, VOS, Quality Control, Leadership, EMEA, cGMP, Best Practices, System Requirements, Life Science, Direct support, Operations, Service, Accountability, PIC, Change Control, Remediation, Quality assurance Originele vacature is te vinden op StepStone.be – Maak nu een Jobagent aan op StepStone en vind je droombaan https://bit.ly/2jPYsZC Vind gelijkaardige jobs, informatie over werkgevers en carrièretips op StepStone.be Original job ad is published on StepStone.be - Set up a Jobagent at StepStone now and find your dream job https://bit.ly/2jPYsZC For similar jobs, information on employers and career tips visit StepStone.be La version originale de cette offre d'emploi est disponible sur stepstone.be – Créez maintenant votre Job Agent sur StepStone et trouvez le job de vos rêves https://bit.ly/2jPYsZC Trouvez des jobs similaires, des informations sur les employeurs qui recrutent et des conseils de carrière sur stepstone.be
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