Inspector, Quality, Brazil

West Pharmaceutical Services, Inc; São Paulo; Presencial; BRL 20.000 - 80.000; Tempo integral

Resumo da oferta

A leading company in the healthcare industry seeks a Quality Analyst in São Paulo. This role involves performing analytical reviews, ensuring compliance with cGMP standards, and supporting quality activities. Ideal candidates will have a relevant degree and some experience in quality assurance.

Qualificações

• Bachelor's degree in Technical Studies or Science preferred.
• 0-3 years of experience required; 2 years of cGMP experience preferred.
• Ability to work independently and in a team.

Responsabilidades

• Perform cGMP Data Review on analytical data.
• Review and approve samples and batch releases.
• Maintain compliance with regulations and procedures.

Conhecimentos

Data Review

cGMP Compliance

Analytical Techniques

Customer Service

Team Collaboration

Formação académica

Bachelor's Degree in Technical Studies or Science

Ferramentas

MS Office

Adobe

MasterControl

LIMS

LMS

SAP

Descrição da oferta de emprego

Select how often (in days) to receive an alert:

Requisition ID: 69813

Date: May 19, 2025

Location:

Sao Paulo, Sao Paulo, BR

Department: Quality

Description:

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

Job Summary

In this role you will be responsible to independently provide analytical review of the data generated for internal and external customers as well as supporting post-production related Quality activities such as finished batch release, including sterilization, packaging specifics, work order approval and support additional quality department activities. This position also requires maintaining knowledge of the current local and/or International regulations/guidelines/policies applicable to West's products and services.

Essential Duties and Responsibilities

• Perform cGMP Data Review on the analytical data generated in Lab Operations which may include raw materials and finished goods, product performance, container closure integrity, particle analysis, and/or microscopy/investigation
• Review the analytical raw data generated by laboratory operations according to established methods, protocols, Compendia and Work Instructions for cGMP compliance
• Review Electronic Data and Audit Trails for data integrity compliance
• Review Lab Operations Methods, Protocols, and Work Instructions for cGMP Compliance
• Responsible to review and approve of samples and / or batch release including review and approval of the finished Device History File documentation and Certificate of Compliance issuing.
• Responsible to review and approve of relevant packaging and respective graphics artwork
• Maintain working knowledge of computer software packages including MS Office suite, Adobe, MasterControl, LIMS, and LMS
• Collaborate as needed on proposed path forward regarding documentation questions
• Support preparations for periodical management reviews
• Initiate processes in SAP as needed related to finished batch release and sterilization processes

Additional Responsibilities

• Provide a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Maintain a clean, orderly, and safe workstation and environment at all times.
• Conform with and abide by all regulations, policies, work procedures, instruction, and safety rules.
• Exhibit regular, reliable, and punctual attendance.
• Perform other duties as assigned based on business needs.
• Keep current with new GMP compliance guidance and internal QA procedures
• Support new GMP compliance guidance and Data Integrity initiatives

Education

• Bachelor's Degree Technical Studies or Science or equivalent experience preferred

Work Experience

• No min required 0-3 years of experience required and
• No min required Minimum 2 years of cGMP experience preferred and

Preferred Knowledge, Skills and Abilities

• Able to be aware of all relevant standard operating procedures as per Company policy
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• Possess ability to work independently and as part of a team with self-motivation, adaptability, and a positive attitude
• Willingness to learn new and review new analytical techniques
• Meet individual and departmental goals as required

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in orderto apply to West, please send an email to [e-mail] . Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.