Analista Sênior de Qualidade – Reclamações e Vigilância

Analista Sênior de Qualidade – Reclamações e Vigilância

Wat we doen

Bij Kenvue realiseren we de buitengewone kracht van dagelijkse verzorging. Gebouwd op meer dan een eeuw erfgoed en geworteld in de wetenschap, zijn we het huis van iconische merken - waaronder NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON'S® en BAND-AID® die je al kent en waar je van houdt. Wetenschap is onze passie; Zorg is ons talent.

Wie we zijn

Ons wereldwijde team bestaat uit ~ 22.000 briljante mensen met een werkcultuur waar elke stem telt en elke bijdrage wordt gewaardeerd. We zijn gepassioneerd door inzichten, innovatie en toegewijd aan het leveren van de beste producten aan onze klanten. Met expertise en empathie betekent een Kenvuer zijn dat je elke dag de kracht hebt om miljoenen mensen te beïnvloeden. We stellen mensen op de eerste plaats, geven er veel om, verdienen vertrouwen met de wetenschap en lossen op met moed - en hebben schitterende kansen voor je klaarliggen! Geef samen met ons vorm aan onze toekomst - en die van jou. Klik voor meer informatie op here.

Rol rapporteert aan:

Director Global Complaint Vigilance

Locatie:

Latin America, Brazil, Sao Paulo, Sao Jose dos Campos

Werklocatie:

Hybride

Wat je gaat doen

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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