Inspector, Quality, Brazil

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

Resumo da oferta

A leading company in the healthcare industry seeks a Quality Analyst to provide analytical review of data and support quality activities. The role involves ensuring compliance with cGMP standards, reviewing analytical data, and collaborating with internal teams. Ideal candidates will have a Bachelor's degree in Technical Studies or Science and 0-3 years of relevant experience.

Qualificações

• 0-3 years of experience required; 2+ years of cGMP experience preferred.
• Awareness of relevant SOPs and policies.
• Ability to work independently and as part of a team.

Responsabilidades

• Perform cGMP Data Review on analytical data from Lab Operations.
• Review analytical raw data for cGMP compliance.
• Collaborate on documentation questions and support management reviews.

Conhecimentos

Analytical skills

Attention to detail

Customer service

Teamwork

Adaptability

Formação académica

Bachelor's Degree in Technical Studies or Science

Ferramentas

MS Office

Adobe

MasterControl

LIMS

LMS

SAP

Descrição da oferta de emprego

At West, we’re a dedicated team connected by a purpose to improve patient lives, which 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 II. Through our work delivering thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s impact on the healthcare industry continues to grow. 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 committed to creating a healthier environment and planet through our sustainability efforts.

Job Summary

In this role, you will independently provide analytical review of data generated for internal and external customers, support post-production quality activities such as finished batch release—including sterilization, packaging specifics, work order approval—and assist with additional quality department activities. Maintaining knowledge of current local and international regulations, guidelines, and policies applicable to West's products and services is also essential.

Essential Duties and Responsibilities

1. Perform cGMP Data Review on analytical data from Lab Operations, which may include raw materials, finished goods, product performance, container closure integrity, particle analysis, and microscopy/investigation.
2. Review analytical raw data according to established methods, protocols, compendia, and work instructions for cGMP compliance.
3. Review electronic data and audit trails for data integrity compliance.
4. Review Lab Operations methods, protocols, and work instructions for cGMP compliance.
5. Review and approve samples and batch releases, including documentation and certificates of compliance.
6. Review and approve relevant packaging and graphics artwork.
7. Maintain working knowledge of computer software including MS Office, Adobe, MasterControl, LIMS, and LMS.
8. Collaborate on documentation questions and support management reviews.
9. Initiate SAP processes related to batch release and sterilization.

Additional Responsibilities

• Provide excellent customer service during interactions with internal and external customers.
• Maintain a clean, safe, and organized workstation and environment.
• Adhere to all regulations, policies, work procedures, and safety rules.
• Exhibit reliable and punctual attendance.
• Perform other duties as needed, supporting new GMP guidance and data integrity initiatives.

Education

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

Work Experience

• 0-3 years of experience required; 2+ years of cGMP experience preferred.

Preferred Knowledge, Skills, and Abilities

• Awareness of relevant SOPs and policies.
• Support and contribute to Lean Sigma programs.
• Ability to work independently and as part of a team, with motivation, adaptability, and a positive attitude.
• Willingness to learn new analytical techniques.
• Ability to meet individual and departmental goals.

West is an equal opportunity employer that values diversity. We do not discriminate based on race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability. For accommodation needs, contact [e-mail]. Employment is contingent upon background and drug screening where permitted by law.