Kenvueは現在、以下求人を募集しております。
ANALISTA SR DE CALIDAD - Fixed Term私たちがしていること
私たちKenvueは、日々のケアが持つ驚くべき力を信じています。100年以上の伝統と科学に根ざし、Neutrogena®, Aveeno®, Tylenol®, Listerine®, Johnson’s® and BAND-AID®など、皆様が既にご存じでご愛用いただいているアイコニックなブランドを提供しています。科学は私たちの情熱であり、ケアは私たちの才能です。
Who We Are
私たちのグローバルチームは、インサイトとイノベーションに情熱を注ぎ、最高の製品をお客様にお届けすることに全力を注ぐ、多様で優秀な22,000人以上の社員で構成されています。専門知識と共感力を備えたKenvuerであることは、毎日何百万人もの人々の生活に影響を与える力を持つことを意味します。私たちは、人を第一に考え、全身全霊をもってケアし、サイエンスで信頼を獲得し、勇気をもって解決します。私たちとあなた自身の未来を、共に切り開いていきましょう。
Role reports to:
COORD QA場所:
Latin America, Mexico, Distrito Federal, Mexico City勤務地:
ハイブリッドあなたがすること
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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