Description

Kenvue is currently recruiting for:

Sr Quality Analyst (12 months - Fixed Term Contract)

This position is based at São José dos Campos - SP - Brazil.

Who We Are

At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we're the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON'S® and BAND-AID® that you already know and love. Science is our passion; care is our talent. Our global team is made up with 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 future-and yours. For more information, click here.

What You Will Do

In this role you will be part of the Latam Quality organization to operate with the quality support of the Internal e External Make operations through enhanced connections with multidisciplinary teams such as Supply Chain, Regulatory affairs, R& D, RMC to deliver and implement regulatory and statutory compliance building trustworthy and effective deliverables in quality and compliance. You will create and promote projects or programs that make valuable contributions for the end-to-end business.

Key Responsibilities

• Perform qualification processes and audits in material suppliers and service providers based on the company's technical documents, guides, and current legislation to comply with Good Manufacturing Practices.

• Elaboration and Risk Analysis applied to manufacturers, suppliers, distributors, and service providers.

• Assist in the processing and evaluation of data, preparing, analyzing, and archiving technical documents and records related to the Supplier Qualification processes, in order to provide continuous improvement and robustness of flows and processes.

• Monitor the supplier, control the technical and legal documentation of the suppliers, perform the periodic processes of requalification, certification and monitor the compliance with action plans from audits to maintain the supplier's compliance status and meet compliance with Good Manufacturing Practices.

• Record and manage quality issues, escalating serious events to leadership.

• Proactively investigate and develop improvements to existing processes or develops new basic processes executing action plans from change controls, CAPAs, internal audits according to established plans and deadlines to provide continuous improvement to the company's processes and compliance with Good Manufacturing Practices.

• Execute the records in the appropriate systems in accordance with the supplier qualification processes to control the acquisition of materials with impact on GMP to comply with the company's legislation and procedures.

• Support the discussion, requirements needed for Quality Agreements with the suppliers.

• Assist in inspections and audits based on current technical and legal documents of the company and related competent regulatory agencies, to comply with Good Manufacturing Practices and legislation.

• Execute the training process for internal auditors and the Self-Inspection process to regularly evaluate the applicability, monitoring and effectiveness of the Quality System, in accordance with the quality standards established in Good Practices (Clinical Manufacturing, Distribution, Laboratory, etc.), Current Legislation and Company Policies.

• Ensure all process and products and any changes to products are performed in compliance with applicable products regulation/requirements and internal procedures.

• Develop and revise standard operating procedures, specific GMP documentation and quality agreement as well.

• Support the quality indicators, metrics (KPIs) as well Quality management review and operational performance.

• Participate and support as required local and regional quality/compliance projects.

• Interpret regulations to provide risk analysis guidance and make decisions about GxP activities accurately.

Qualifications

What We Are Looking For

Required Qualifications

• Bachelor's degree in pharmacy, chemistry or related science is required. Pharmacy is preferred.

• Proven experience of at least 5 years in a regulated industry (Good Manufacturing Practices and Quality).

• Knowledge in Drug products is required.

• Experience in pharmaceutical industries performing activities related to supplier qualification and on-site audits in suppliers of raw materials, packaging materials and active pharmaceutical ingredients (including experience with Brazilian regulation - DIFA/CADIFA) and services (mandatory).

• Experience with national and international audits.

• Knowledge of current regulatory frameworks related to Good Manufacturing Practices related to the manufacture of medicines.

• Knowledge on regulatory requirements across LatAm region such as ANVISA, COFEPRIS, INVIMA, ANMAT is a key skill.

• Knowledge of risk analysis tools applied to Supplier Qualification.

• Advanced English is required, Spanish is desired.

• Working knowledge of CAPA, Change Control, and General Quality Systems process.

• Advanced technical training and experience using Statistics, Lean and Six Sigma Methodologies is a differential.

• Good communication, organizational and interpersonal skills.

• Advanced knowledge of Microsoft Office (Excel, Power Point, Word).

• Travel availability.

• Must have an active driver's license (for inspection of suppliers).

• Format: 100% on-site.

What's In It For You

• Competitive Benefit Package

• Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!

• Learning & Development Opportunities

• Employee Resource Groups

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.