Inspector, Quality, Brazil

Requisition ID: 68070
- Date: Jan 7, 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

**Additional Requirements**:

- Ability to learn, understand, and remember normal tasks.
- Ability to hear, speak, and understand conversation in English in a normal tone of voice.
- Must maintain the ability to work well with others in a variety of situations.
- Must be able to multi-task, work under time constraints, problem solve, and prioritize.
- Read and interpret data, information and documents
- Work under deadlines with constant interruptions