Overview
This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.
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Support for Parents
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Continuing Education/
Professional Development -
Employee Health &
Well-Being Benefits -
Paid Time Off
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2 Days a Year to Volunteer
Success Profile
What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.
- Detail Oriented
- Continuous Learner
- Courageous
- Collaborative
- Critical Thinker
- Influential
QA Supervisor - QP 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 QA Supervisor - QP for Benelux local entities
Responsible for assuring storage and distribution activities are in line with European and local legal requirements and Corporate Quality Systems implementation in the Benelux local entities (Baxter Belgium SRL and Baxter BV (NL)) including PSE (Productivity Systems Europe) 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 different Benelux local entities (Baxter Belgium SRL and Baxter BV (NL)) and responsible for assuring maintenance of related regulatory licenses (GDP, Opium, medical device notification) and as Qualified Person (QP) for Baxter Belgium SRL compounding 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 (Baxter SRL, Baxter BV, Productivity System Europe)
Ensuring that appropriate contacts with country Regulatory Affairs, Pharmacovigilance, W&D, Compounding services, Businesses and Distributors are maintained
ESSENTIAL DUTIES AND RESPONSIBILITIES
Legal role: Responsible Person (including being the MoH single point of contact for materiovigilance
- For Baxter BV (NL):
Act as Responsible Person (RP) for distribution. This includes assuring QMS functioning according to GDP guidelines including covering oversight on customer activation, code activation, returns, discards, administrative releases, complaints, FA’s, subcontracted activities within Baxter organization, …
- For Baxter Belgium SRL:
Act as Responsible Person (RP) for distribution. This includes assuring QMS functioning according to GDP guidelines including covering oversight on customer activation, code activation, returns, discards, administrative releases, complaints, FA’s, subcontracted activities within Baxter organization, …
Act as Qualified Person (QP) for Compounding license.
- Be the contact person for all FMD topics for Benelux (alert management, falsified notification, compliance questions, returns, …)
- Assure timely notification of major changes to MoH inspection where needed
- Assure regular training on GDP in relation with the legal role
Quality systems and Baxter role:
Be the contact person for Benelux operations and Quality Systems
Act as Quality Management Representative for CQA Benelux
Ensure process and procedures are in place and in compliance with European, Local and Corporate requirements
Postmarket surveillance:
Manage and treat tasks related to materiovigilance, product quality complaint and Field Actions
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, answer to the customers on complaints.
Ensure training of customer facing employees on PQCs and Materiovigilance is performed.
Maintain safe complaint sample procedures
Improve complaint handling systems constantly
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 Field Action Local Coordinator are appropriately trained
Act as back-up for the Field Action Local Coordinator & the LCC when required
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 CQA Benelux (and local entities when needed), act as lead auditor
Participate to Global Compliance Audits and external quality audits ISO9001 accreditation (TÜV)
Host Regulatory compliance inspections, notified body (TUV 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
Assure issuing of SCAR in case of supplier issue
Act as auditor for local supplier audit when needed
Training:
Assure that systems are in place and maintained to train CQA 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 and CQA)
EHS Roles and responsibilities:
Each employee is responsible, according to his/her possibilities, to take care from his/her safety and his/her health as well as from those of other people concerned by his/her actions or omissions at work, in accordance with his/her training and with the instructions from his/her employer:
Uses correctly the machines, devices, tools, transportation equipments and other means
Uses correctly the Individual protection equipment (IPE)
Uses correctly the safety devices
Reports immediately to the employer any safety non-conformance and especially in case of severe and immediate danger
Controls the conformance of the installations and area before starting any activity (especially after each change)
Proposes solutions for improvement regarding the safety of work conditions
Participates positively to the policy on violence prevention, moral and sexual harassment at work.
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, …)
LOCATION OF THE FUNCTION
60% Braine l'Alleud + 40% Lessines
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
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