Analista Sênior de Qualidade – Reclamações e Vigilância

Was wir tun

Bei Kenvue erkennen wir die außergewöhnliche Kraft der täglichen Pflege. Aufbauend auf über einem Jahrhundert Tradition und verwurzelt in der Wissenschaft, sind wir das Haus der ikonischen Marken - darunter NEUTROGENA®, AVEENO®, TYLENOL,® LISTERINE®, JOHNSON'S® und BAND-AID®, die Sie bereits kennen und lieben. Wissenschaft ist unsere Leidenschaft; Fürsorge ist unser Talent.

Wer wir sind

Unser globales Team besteht aus ~ 22.000 brillanten Mitarbeitern mit einer Arbeitsplatzkultur, in der jede Stimme zählt und jeder Beitrag geschätzt wird. Wir sind leidenschaftlich an Erkenntnissen interessiert, Innovation und dem Engagement, unseren Kunden die besten Produkte zu liefern. Mit Fachwissen und Einfühlungsvermögen bedeutet ein Kenvuer zu sein, die Macht zu haben, jeden Tag Millionen von Menschen zu beeinflussen. Wir stellen den Menschen an die erste Stelle, kümmern uns leidenschaftlich, gewinnen Vertrauen in der Wissenschaft und lösen Lösungen mit Mut – und haben brillante Möglichkeiten, die auf Sie warten! Gestalten Sie mit uns unsere Zukunft – und Ihre. Für weitere Informationen, klicken Sie auf hier.

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Was Sie tun werden

Atualmente estamos com 4 posições abertas para Analista Senior.

The SR COMPLAINT VIGILANCE ANALYST is responsible for processing product quality complaints and supporting day-to-day activities for complaint management for the North America region and globally (as needed) including but not limited to:

Key Responsibilities

• Evaluate complaints in alignment with the product quality complaint program. This may include, but is not limited to, trend analysis, assignment of complaint to manufacturing site, review of manufacturing site investigation, complaint closure as applicable, and escalation as needed.
• Review and process updated information for complaint change logs from the call center and medical safety to assess impact on triage and investigation process.
• Collaborate with cross-functional teams such as Global Consumer Care, Medical Safety Internal affiliates and External site representatives to address and resolve complaints efficiently.
• Complete Annual Drug Product Review contributions, Complaint Vigilance reports, and presentations per established procedures. Prepare and issue meeting minutes and ensure action items are complete.
• Assist with/participates in various projects and activities related to Complaint Vigilance processes, system implementations, and improvements.
• Monitor Complaint Records in the complaint management system to ensure standard processes are being followed and complaints are closed as required.
• Compile product and lot-specific complaint trending data and complaint closure metrics as requested.
• Support internal and external audits and inspections as a Subject Matter Expert as needed.
• Provide training and guidance to junior analysts on complaint vigilance processes and procedures.
• As necessary, this position will support the Analyst functions in other Geographical regions for Consumer products.

Required Qualifications

• Bachelor’s Degree in Science/Engineering or a related discipline
• Minimum 5 years of related experience in Quality Assurance and/or complaint management in pharmaceutical, medical device, nutritional or related industry experience
• Detail-oriented with the ability to document and track corrective actions and complaint investigations.
• Knowledge of regulatory requirements and quality assurance processes in the healthcare industry
• Proficiency in the use of computer systems and applications such as Microsoft Office Suite
• Strong analytical skills with the ability to interpret complex data and identify trends.
• Ability to work independently and prioritize tasks in a fast-paced environment.
• Language Requirement: Both Portuguese and English (effectively writing & speaking)

Desired Qualifications

• Excellent communication and interpersonal skills to effectively collaborate with internal and external stakeholders.
• Problem-solving abilities and focus on accuracy and precision in data analysis and reporting.
• Advanced skills in PowerPoint and Excel include v-look up, H look-up, macros, and pivot tables.
• Experience supporting manufacturing, packaging, and development operations.
• Experience with complaint handling software applications.
• Experience with systems and tools supporting analysis and reporting including Power BI, Tableau.

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