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Braine-l'Alleud

    Primary Packaging Quality Lead - Braine-l'Alleud, België - UCB

    UCB
    UCB Braine-l'Alleud, België

    2 weken geleden

    ucb background
    Beschrijving

    Make your mark for patients

    We are looking for a Primary Packaging Quality Lead to join us in our Devices and Wearable Tech. Quality team, based in our office in Bulle, Switzerland.

    About the role

    This global position drives operational Quality Assurance activities for development and commercial activities related to Primary packaging (stand-alone or part of a combination product) internally and at key vendors. It will as well provide specific internal QA support/consultancy Primary packaging. 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 do

    Provide 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 Primary packaging 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 required
  • Review 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 place
  • Support 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 plan
  • Review and approve submissions and responses

    • Vendor quality management

  • Accommodate design & technology transfer and ensure systems alignment between vendor and UCB
  • Performing focused assessments/audits
  • Preparation and negotiation of Quality Agreements
  • Ensure systems alignment between vendor and UCB
  • Facilitate quality improvement activities at vendors and UCB systems
  • Support risk register for the vendor, and follow up on mitigation activities
  • Monitor and trend vendor performance
  • Authority to accept release or block release of Primary packaging components
  • Oversee inspection plans at CMO and UCB

    • Quality processes

  • Facilitate investigations and resolution of issues relating to deviation and change management
  • Review and approve deviations
  • Lead/review critical investigations
  • Track CAPA events and closure
  • Oversee/track change controls

    • Provide expert advice and support on operational and general QA activities for projects part of the devices and primary packaging portfolio (Process improvement, Technology Transfers, New products or life-cycle management...):

  • Act as the Operational QA link between selected external vendors within the Primary packaging portfolio
  • Assist with regulatory and customer inspections at Vendors. Specifically focus on: Inspection preparation, Support during inspection, Support post inspection observation closure
  • Work 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 way
  • Work 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 development
  • Support additional projects as requested
  • Provide 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 manner
  • Drive/Support projects related to quality system improvement
  • Maintain key performance indicators (metrics) for key operational development QA activities and services associated with the Medical Devices, Combination Products and primary packaging activities
  • Maintain GMP compliance and inspection/audit readiness at all times. Support Medical Devices and Primary packaging departments in the inspection/audit preparation activities, during inspection/audit and for closure of inspection/audit observation with associated CAPA commitments
  • Support Medical Devices, Combination Products and primary packaging related inspections
  • Support Management Review Process
  • Support Design Reviews

    • I nterested? For this role we're looking for the following education, experience and skills

  • Should 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 advantage

    • If you are interested to learn more about R&D within UCB, please find more information here .

    RANDATUCB

    Are 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

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