R&D Senior Quality & Compliance Analyst

Brazil Job Openings

Kenvue

São José dos Campos

October 23, 2024

Description

Kenvue is currently recruiting for:
R&D Senior Quality & Compliance Analyst

This position reports to Franchise Quality Manager and is based at São José dos Campos.
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® Brand Adhesive Bandages that you already know and love. Science is our passion; care is our talent. Our global team is made up of ~ 22,000 diverse and brilliant people, passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact the 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.
Role reports to: Quality & Compliance Manager

Location: São José dos Campos

Travel %: 10%

What you will do
The R&D Senior Quality & Compliance Analyst is responsible a Q&C representative in the R&D organization, being responsible for all quality activities related to Gx P laboratories and R&D product development activities. Focuses on solving technical problems related to the interpretation and implementation of regulations, compliance and standards within the scope of its activities. This professional shall have a deep technical knowledge to attend internal / external and regulatory audits, and knowledge of quality tools and laboratory management.

Key Responsibilities

Ensure attendance to the Gx P requirements for Pilot Plant and R&D Labs.

Revise and approve protocols and reports related to test methods development and validations, equipment management and other required activities.

Develop and revise standard operating procedures and specific GMP/GLP documentation within R&D Compliance processes and R&D processes

Proactively investigates and develops improvements to existing processes or develops new processes.

Conduct batch record reviews and issue product certificate of conformance.

Lead compliance projects to promote continuous improvement within R&D specific processes for pilot plant and/or R&D laboratories

Interact with and provide guidance to R&D professionals on Gx P regulatory requirements.

Interpret regulations to provide risk analysis guidance and make decisions about R&D Gx P activities accurately.

Lead and/or support the internal and external Q&C audit program, regulatory inspections and Inspection Readiness Program.

Lead investigations, CAPA and change controls.

Qualifications

What we are looking for

Required Qualifications

Bachelor’s Degree in Pharmacy, Chemistry, Engineering or related science is required. Pharmacy is preferred.

Proven experience of at least 4 - 6 years in a regulated industry. Pharmaceutical Industry is preferred.

Experience in quality control and/or analytical development laboratory

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

Knowledge of regulatory environment related to laboratory and method development and validation.

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

Advanced English

Desired Qualifications

Knowledge on regulatory requirements for North America such as FDA.

Excellent problem-solving and analytical skills.

Excellent communication and coaching skills.

Experience in conducting audits for compliance

Advanced technical training and experience using Statistics, Lean and Six Sigma Methodologies.

What’s in it for you

Competitive Total Rewards Package*

Paid Company Holidays, Paid Vacation, Volunteer Time & More!

Learning & Development Opportunities

Employee Resource Groups

This list could vary based on location/region

Note: Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process.

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

Primary Location Latin America-Brazil-São Paulo-São José dos Campos

Job Function R&D

We regret to inform you that this job opportunity is no longer available as it has expired

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