Descripción general
Aquí es donde usted marca la diferencia en la seguridad de nuestros pacientes. Como miembro del equipo de Calidad de Baxter, desempeñará un papel esencial en nuestra misión de salvar y sostener vidas. La calidad es importante durante todo el ciclo de vida del producto y trabaja en colaboración con todas las áreas de la organización. Debido a que Calidad afecta todo lo que hace Baxter, un rol en Calidad brinda muchas oportunidades de crecimiento, aprendizaje y una carrera exitosa que tiene un impacto diario en la vida de las personas.
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Apoyo a las padres
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Educación continua/
Desarrollo profesional -
Salud de los empleados y &
Beneficios de bienestar -
Tiempo libre pagado
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2 días al año para ser voluntario
Perfil de éxito
¿Qué hace que un miembro del equipo de calidad de Baxter sea exitoso? Revise algunos de los rasgos principales que estamos buscando y vea si su perfil se ajusta.
- Orientado al detalle
- Aprendiz continuo
- Valiente
- Colaborativo
- Pensador crítico
- Influyente
Specialist, CQA Benelux
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, …)
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
DIRECCIÓN
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