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Vaga de Sr. Complaint Vigilance Analyst

1 vaga: | Publicada em 04/07

Sobre a vaga

Sr. Complaint Vigilance Analyst-2407022430WDescriptionKenvue is currently recruiting for:Sr.ComplaintVigilance AnalystThe Sr.Complaint VigilanceAnalyst oversees the execution and oversightofComplaint Vigilance in conformance to currentstandards and procedures, usingapplicablesystem application tools(e.g.,PQMS,EVIREST). Guide the staff ofprofessionals who execute the complaintvigilanceprocess.Thisrole participates in regional and global complaint vigilanceinitiatives to improvecomplaintvigilanceprocesses andrepresents Complaint Vigilance with internal and external audits inLATAM region (e.g., JJRC and Health Authorities inspections). Participates in project teams to develop,consolidate, and/or improve complaintvigilance and related/interfacingprocesses. The Sr.Complaint VigilanceAnalyst ensurescompliance with corporate policies and procedures, internal requirements,and regulatoryagencyrequirements asthey relate toComplaintVigilance.As needed, theSr.Complaint VigilanceAnalyst willassist intriage activities as,evaluates anddeterminesifinvestigationis necessaryfor productquality complaintsand adverseevents for non-deviceKenvue products in accordance with StandardOperating Procedures using the Product Quality Management System.Developing training presentationsfor complaintvigilanceprocessand systems and creationand updates ofcontrolled documents.As necessary,this position willsupport theTriagefunction inother Geographical regions forConsumer products. The position will as necessarily act as Manager designee for the Second Level approval of productquality complaintsand adverseevents for non-deviceKenvue products. QualificationsRequirements: "Aminimumofa bachelors degree is required.A focus in Science,Engineering,orrelated discipline is preferred."Aminimumof5 years ofrelated experienceincludingQuality Assurance and/or QualityControl is required."Experience working in pharmaceutical,medicaldevices or otherrelated or highly regulated industry is required."Demonstrated knowledgeand expertisein quality processes and regulatoryrequirements is required."Experience working in aregulatedenvironment is required. OtherPreferred Experiences: "Experiencesupporting manufacturing, packaging, and developmentoperationsis preferred."Experiencesupporting many/all aspectsofthe complaintvigilancelife cycle for pharmaceutical,device, and /orcosmetic productsis preferred. "Experience withone or more technologiessupportingcomplainthandling preferred."Experience in the creation,update,and managementofcomplaintfilesfromcomplaint identification throughclosure required."Expertisewith root cause analysis techniques including butnot limited to:Brainstorming,dataanalysis and collectiontools, 5 Whys,Fishbone (Causeand Effect),FMEA,and DMAIC preferred"Experience withtools and techniquessupporting qualitative riskanalysis including butnot limited to: Probability and impact assessment (likelihood ofrecurrenceand potential effect),probability and impact matrix(riskratings,ratingrules),and risk categorization (by rootcauses, otherqualifiers)is preferred"Experience withsystems and toolssupportinganalysis and reporting preferred. Who We AreAt , we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, were the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSONS® and BAND-AID® that you already know and love. Science is our passion; care is our talent. Our global team is made by 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage  and have brilliant opportunities waiting for you! Join us in shaping our futureand yours. For more information, .Primary LocationLatin America-Brazil-São Paulo-São José dos CamposJob FunctionQuality Assurance