Quality assurance- Complaints Specialist

Novartis Farmacéutica; Santo Amaro; Presencial; BRL 40.000 - 80.000; Tempo integral

Resumo da oferta

An established industry player is looking for a Quality Assurance - Complaints Specialist to manage quality aspects and projects. This role is crucial in ensuring compliance with GxP standards and Novartis Quality Management Systems. You will handle complaints, conduct investigations, and evaluate information to ensure quality review. Join a passionate community dedicated to making a difference in patients' lives and help create a brighter future together.

Qualificações

• Minimum 3 years of experience in complaints handling and investigations.
• Experience in QC/QA within the pharmaceutical or biotech industry.

Responsabilidades

• Ensure on-time and GMP-compliant release of dosage forms.
• Manage complaints including entry, follow-ups, and product analysis.
• Conduct daily complaint analysis and failure investigations.

Conhecimentos

Dealing with ambiguity

GMP procedures

Quality Assurance (QA)

Quality Control (QC) Testing

Knowledge of quality standards

Technological expertise

Descrição da oferta de emprego

Quality Assurance - Complaints Specialist

Job ID REQ-10050372

May 02, 2025

Summary

Manages quality aspects and projects within the area of responsibility. Ensures and supports overall GxP conformity and compliance with Novartis Quality Management Systems.

About the Role

Responsibilities:

• Ensure on-time and GMP-compliant release of dosage forms.
• Manage complaints, including entry, follow-ups, product analysis, and closure.
• Develop and establish reports for prompt review of new complaints, regulatory reporting decisions, and follow-up actions.
• Code events and ensure all required information for complaint files is obtained and properly documented.
• Evaluate all information from clinical and technical perspectives to ensure appropriate analysis, investigation, root cause determination, and quality review.
• Track, receive, and ship products as needed.
• Conduct daily complaint analysis and failure investigations, documenting results and relevant information.
• Approve complaints within assigned product families.
• Set up complaint meetings and communicate effectively with worldwide complaint groups and internal departments.

Qualifications:

• Minimum 3 years of experience in complaints handling and investigations.
• Experience in QC/QA within the pharmaceutical or biotech industry, including environmental monitoring.

Skills:

• Dealing with ambiguity
• GMP procedures
• Quality Assurance (QA)
• Quality Control (QC) Testing
• Knowledge of quality standards
• Technological expertise

Languages:

Specify language requirements here (if any).

Why Novartis

Helping people with diseases and their families requires more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting, and inspiring each other to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? Learn more

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BR03 (FCRS = BR003) NOVARTIS BIOCIENCIAS S.A