ANALISTA SR DE CALIDAD - Fixed Term

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

The Analista Sr de Calidad – Source Quality will be part of the LatAm Source Quality organization and is responsible for the quality & compliance oversight for the External Suppliers and projects including, but not limited to, the evaluation and risk-based analysis of Quality aspects of New Product Introduction, Business Development and Changes to Existing Products.

Key Responsibilities

• Participate in local and regional quality/compliance projects and act as the Quality voice for New Product Introduction and New Business Development in LATAM. Guarantee project’s activities are completed on time.
• Ensure projects’ compliance, accuracy, and alignment with company policies, procedures and quality standards.
• Provide risk-based analysis of Quality aspects related to New Product Introduction and New Business Development
• Understand current and emerging regulations and impact to quality of OTC keeping affiliates/EM located in other regions updated and compliant on new regulations.
• Partner with adjacent areas of the business to build a robust strategy to achieve the committed goals.
• Ensure all products meet and/or exceed company and local government standards evaluating regulations to provide risk analysis guidance and make decisions about GxP activities accurately.
• Lead external audits, supplier’s selection, qualification and monitoring tasks to attend regulations and Kenvue requirements.
• Collaborate cross-functionally with engineering, product, operations, and other quality teams to embed quality-centric practices, update and improve documentation including standard operating procedures, external supplier documents (including process validation, analytical transfers), and support new product development procedures throughout the development lifecycle.

What we are looking for

Required Qualifications

• Bachelor’s degree or equivalent in Engineering, Computer Science, Data Analytics, or a related field
• Proven experience of at least 4 - 6 years in a regulated industry. Pharmaceutical Industry is preferred.
• Knowledge in Drug Product Manufacturing and Controls.
• Knowledge on regulatory requirements across LatAm region such as ANVISA, COFEPRIS, INVIMA, ANMAT.
• Working knowledge of CAPA, Change Control, and General Quality Systems process.
• Knowledge in Process Validation.
• Knowledge in Process/Analytical Transfers.
• Strong foundational knowledge of quality management principles
• Effective communication skills to collaborate with cross-functional teams and support quality initiatives.
• Strong analytical and problem-solving skills with experience in interpreting data and generating quality reports.
• Advanced knowledge of Microsoft Office (Excel, Power Point, Word).
• Advanced to Fluent English.

Desired Qualifications

• Basic to Intermediate Portuguese.
• Advanced technical training and experience using Statistics, Lean and Six Sigma Methodologies.
• Strong analytic skills – Ability to standardize varying data process/inputs.
• Intellectual agility, curiosity, and creativity.
• Good communication skills to effectively articulate quality insights and influence stakeholders at all organizational levels.

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