Quality Assurance Specialist II

Thermo Fisher Scientific Inc.; São Paulo; Híbrido; BRL 60.000 - 80.000; Tempo integral

Resumo da oferta

A leading company in the life sciences sector is seeking a Quality Assurance professional to ensure compliance with Good Manufacturing Practices. The role involves managing quality documentation, conducting audits, and supporting quality control activities. The position offers a hybrid work model, requiring 3 days in the office and 2 days at home, with a focus on safety and efficiency.

Qualificações

• Experience with Good Manufacturing Practices (GMP) and Safety Standards.
• Knowledge of quality documentation and GxP principles.

Responsabilidades

• Support Quality Assurance and Quality Control compliance.
• Manage quality documentation issuance and revision.
• Conduct self-inspection audits and support Quality Control activities.

Conhecimentos

Advanced English

Descrição da oferta de emprego

Work Schedule

Flex Shifts, 40 hrs/wk

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) and Safety Standards. Office environment, some PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs, etc.), Warehouse environment.

Job Description

1. Provide support to Quality Assurance and Quality Control to ensure compliance with good manufacturing, distribution, clinical, and documentation practices.
2. Issue updates to local procedures based on global procedures, local regulations, and operational requirements.
3. Lead GxP training distribution via LMS system and/or classroom sessions.
4. Manage issuance, revision, obsolescence, and archiving of quality documentation following GxP and ALCOA principles.
5. Participate in validation, qualification, maintenance, and calibration of equipment and GxP areas.
6. Conduct self-inspection audits of supplier assessments, audits, qualification, and the development of Quality Technical Agreements.
7. Support Quality Control activities such as physical inspections and batch releases in quality systems (GPM and CTWin), as well as shippers and materials inspection and release.
8. Follow up on Deviations, Complaints, and CAPAs.
9. Ensure accurate execution of operational processes.
10. Carry out all activities with a focus on safety and efficiency.

Advanced / Fluent English is mandatory.

Availability to work at Jaguaré - São Paulo/SP. Hybrid work model: 3 days in the office, 2 days at home.