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Braine-l'Alleud

    Specialist, CQA Benelux - Braine-l'Alleud, België - Baxter

    Baxter
    Baxter Braine-l'Alleud, België

    5 dagen geleden

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    This is where you save and sustain lives

    At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

    Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

    Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

    Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

    SUMMARY

  • Be the CQA Specialist for Benelux local entities, reporting to the cQA/RA Manager Benelux.
  • Responsible for ensuring storage and distribution activities are in line with European and local legal requirements and Corporate Quality Systems implementation in the Benelux local entities (KidneyCo Belgium SRL and KidneyCo BV (NL) to ensure establishment and maintenance of required licenses (e.g. GDP Wholesaler, ISO 9001 and ISO 13485 certifications)
  • Authorized to act as the Responsible Person (RP) for the Benelux local entities KidneyCo Belgium SRL and KidneyCo BV (NL) and responsible for ensuring maintenance of related regulatory licenses (GDP, medical device notification) and as Qualified Person (QP) for KidneyCo Belgium SRL MIA license
  • Act as the Post Market Surveillance Local contact person and local contact person for medical devices
  • Responsible for Quality Support to local business initiatives in collaboration with Quality Operations (KidneyCo Belgium SRL, KidneyCo BV)
  • Ensuring that appropriate contacts with country Regulatory Affairs, Pharmacovigilance, third party logistics (3PL) for Warehouse & Distribution (W&D), Businesses and Distributors are maintained.

    • ESSENTIAL DUTIES AND RESPONSIBILITIES

    Legal role: Responsible Person

    For KidneyCo BV (NL):

  • Act as Responsible Person (RP) for distribution. This includes ensuring QMS functioning according to GDP guidelines including covering oversight on customer activation, code activation, returns, discards, administrative releases, complaints, Field Actions (FA's), subcontracted activities within KidneyCo organization, ...

    • For KidneyCo Belgium SRL:

  • Act as Responsible Person (RP) for distribution. This includes ensuring QMS functioning according to GDP guidelines including covering oversight on customer activation, code activation, returns, discards, administrative releases, complaints, FA's, subcontracted activities within KidneyCo organization, ...
  • Act as Qualified Person (QP) for MIA license.

    • Be the contact person for all FMD topics for Benelux (alert management, falsified notification, compliance questions, returns, ...)

    Ensure timely notification of major changes to MoH inspection where needed.

    Ensure regular training on GDP in relation with the legal role.

    Quality systems role:

  • Be the contact person for Benelux operations and Quality Systems
  • Be the QA contact person for the 3PL W&D
  • Act as Quality Management Representative for QA/RA Benelux
  • Ensure process and procedures are in place and in compliance with European, Local and Corporate requirements.

    • Postmarket surveillance (PMS):

  • Keep oversight on management and treatment of tasks related to materiovigilance and product quality complaint (PQCs)
  • Act as FA coordinator for Benelux
  • Act as local materiovigilance contact person for internal and external stakeholder
  • Ensure answer to safety questions from the Health Care Professionals is provided with the support of PMS, Medical Safety and relevant functions.
  • Ensure training of customer facing employees on PQCs and Materiovigilance is performed.
  • Investigate/prepare/communicate on questions from MoH's, with the support of PMS if needed
  • Ensure Field Actions are executed in due time according to procedures and regulations applicable and in collaboration with corporate functions and requirements
  • Ensure process and procedures are in place
  • Ensure periodic reporting to internal stakeholders on FA and complaints

    • Quality support to business – Treat product quality issues in due time and in relationship with the business

  • Be the contact with the plants for quality problems
  • Participate in business projects (new products, distribution, etc...) as quality representative to assure compliance

    • Audits and Inspections:

  • Participate in the annual internal audit program of QA/RA Benelux (and local entities when needed), act as lead auditor
  • Host Regulatory compliance inspections (notified body and MOH)

    • NCR, SNCR, CAPA, change control & supplier quality:

  • Initiate NCR, SNCR and CAPA when it is required
  • Assure change control system is in place and followed
  • Assist in or perform CAPA's & change controls launched for Benelux
  • Take the quality lead in Business projects in which supplier quality aspects are included
  • Ensure issuing of SCAR in case of supplier issue
  • Act as auditor for local supplier audit when needed

    • Training:

  • Ensure that systems are in place and maintained to train QA/RA in quality system compliance (including new SOP's).
  • Ensure training records are maintained
  • Give training on request or when required to other personnel (W&D, QA/RA, customer service, ...)

    • JOB REQUIREMENTS

    Master Degree in Pharmaceutical Sciences and/or Advanced Master in Industrial Pharmacy

    Certified QP from Belgian FAMHP

    Fluency in French & English and Dutch

    Word, Excel, Outlook, PowerPoint basic knowledge required

    Trackwise, JDE, ERP system particular knowledge required

    Knowledge of ISO, GDP and GMP standards and applicable quality systems in area of responsibility

    Product and process validation methodology

    Knowledge of Medical Industry Processes

    IT functional knowledge (ERP systems, data management systems, ...)

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