Société : UCB Lieu : Braine-l'Alleud Wallonia Site source : Talent BE
This will be achieved through close partnering with QA management at vendors sites and collaboration with UCB Technical Operations and other UCB teams.This position will ensure compliance to Medical Devices regulations, ISO requirements and GMP/cGMP compliance from a quality, safety and efficacy point of view.What you’ll doProvide expert advice, support and management for technical operational QA and general QA matters for specific vendors, on behalf of UCB, in design/development and/or testing/manufacturing of Primarypackaging ensuring application of MDR, ISO and GMP/cGMP requirements.
Specifically focused on the following:
Design and development Quality assurance:
Oversee Design & Development activities, from Planning, Inputs definition through Design Transfer (including Validation/Verification activities)Review and approve relevant sections of the design control documentation and/or Technical Documentation File as requiredReview and approve protocols and reports for Verification & Validation studies, technology transfers, stability studies, etc…Review and approve UCB documentation.
Ensure Design History File (DHF) is in placeSupport Risk Management Activities including QbD (Quality by Design) activities.
Ensure risk assessments are performed at appropriate stages of development/commercialization and for decision making on issues arising.
Ensure deliverables are issued in accordance with the D&D planReview and approve submissions and responsesVendor quality managementAccommodate design & technology transfer and ensure systems alignment between vendor and UCBPerforming focused assessments/auditsPreparation and negotiation of Quality AgreementsEnsure systems alignment between vendor and UCBFacilitate quality improvement activities at vendors and UCB systemsSupport risk register for the vendor, and follow up on mitigation activitiesMonitor and trend vendor performanceAuthority to accept release or block release of Primarypackaging componentsOversee inspection plans at CMO and UCB Quality processesFacilitate investigations and resolution of issues relating to deviation and change managementReview and approve deviations Lead/review critical investigationsTrack CAPA events and closureOversee/track change controlsProvide expert advice and support on operational and general QA activities for projects part of the devices and primarypackaging portfolio (Process improvement, Technology Transfers, New products or life-cycle management…):
Act as the Operational QA link between selected external vendors within the Primarypackaging portfolioAssist with regulatory and customer inspections at Vendors.
Specifically focus on:
Inspection preparation, Support during inspection, Support post inspection observation closureWork closely with staff in the Corporate QA teams (especially CM&C, Clinical Supply QA, Corporate Compliance and Affiliate Quality Services) and key Technical Operations teams/Affiliate teams to ensure that all QA services for selected critical vendors are provided in an effective and efficient wayWork in accordance with HSE and Corporate policy requirements and drive personal training and development activities to meet the needs of the business and professional career developmentSupport additional projects as requestedProvide on-site presence ‘in plant’ or on site at vendor General GMP:
Maintain Quality System elements associated with the ISO, MDR and GMP activities in a compliant mannerDrive/Support projects related to quality system improvementMaintain key performance indicators (metrics) for key operational development QA activities and services associated with the Medical Devices, Combination Products and primarypackaging activitiesMaintain GMP compliance and inspection/audit readiness at all times.
Support Medical Devices and Primarypackaging departments in the inspection/audit preparation activities, during inspection/audit and for closure of inspection/audit observation with associated CAPA commitmentsSupport Medical Devices, Combination Products and primarypackaging related inspectionsSupport Management Review ProcessSupport Design ReviewsInterested? For this role we’re looking for the followingeducation, experienceand skillsShould have a US and EU knowledge of pharmaceutical (and medical devices would be a plus) regulations together with quality principles and techniques.Take accountability for decisions and actions taken.Be proactive, confident and enthusiastic during the interaction with colleagues during teamwork and take the initiative to promote and share/implement best practices.Must possess good interpersonal, verbal, and written communication skills and be able to confidently present information at interdepartmental and external meetings.
Ensure free flow of information throughout the sphere of work.Root cause analysis and risk management/assessment skills will be a distinct advantageIf you are interested to learn more about R&D within UCB, please find more information here .RANDATUCBAre you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you! UCB Braine-l'AlleudWallonia
