Company : Baxter Location : Braine-l'Alleud Wallonia From : Talent BE
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 licenseAct as the Post Market Surveillance Local contact person and local contact person for medical devicesResponsible 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&DAct 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 BeneluxAct as local materiovigilance contact person for internal and external stakeholderEnsure 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 neededEnsure Field Actions are executed in due time according to procedures and regulations applicable and in collaboration with corporate functions and requirementsEnsure process and procedures are in placeEnsure periodic reporting to internal stakeholders on FA and complaintsQuality support to business – Treat product quality issues in due time and in relationship with the businessBe the contact with the plants for quality problemsParticipate 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 auditorHost Regulatory compliance inspections (notified body and MOH)NCR, SNCR, CAPA, change control & supplier quality:
Initiate NCR, SNCR and CAPA when it is requiredAssure change control system is in place and followedAssist in or perform CAPA’s & change controls launched for BeneluxTake the quality lead in Business projects in which supplier quality aspects are includedEnsure issuing of SCAR in case of supplier issueAct as auditor for local supplier audit when neededTraining:
Ensure that systems are in place and maintained to train QA/RA in quality system compliance (including new SOP’s).
Ensure training records are maintainedGive training on request or when required to other personnel (W&D, QA/RA, customer service, …) JOB REQUIREMENTSMaster Degree in Pharmaceutical Sciences and/or Advanced Master in Industrial PharmacyCertified QP from Belgian FAMHPFluency in French & English and DutchWord, Excel, Outlook, PowerPoint basic knowledge requiredTrackwise, JDE, ERP system particular knowledge requiredKnowledge of ISO, GDP and GMP standards and applicable quality systems in area of responsibilityProduct and process validation methodologyKnowledge of Medical Industry ProcessesIT functional knowledge (ERP systems, data management systems, …) Baxter Braine-l'AlleudWallonia
