Analista de Garantia de Qualidade Senior

Novartis Farmacéutica; Cambé; Presencial; BRL 80.000 - 120.000; Tempo integral

Resumo da oferta

A leading company in the pharmaceutical sector is seeking a Quality Assurance Manager to oversee the quality aspects within production. The successful candidate will ensure compliance with regulatory standards, support continuous improvement projects, and manage the release of pharmaceutical batches, contributing significantly to the company's commitment to quality and excellence.

Qualificações

• Experience in Quality Assurance and GMP standards.
• Strong understanding of compliance in a pharmaceutical environment.

Responsabilidades

• Oversee production and testing activities ensuring compliance with cGxP.
• Support investigations and quality improvement projects.
• Execute batch release per regulatory compliance.

Conhecimentos

Dealing with ambiguity

GMP procedures

Quality Assurance (QA)

Quality Control (QC) testing

Knowledge of quality standards

Technological expertise

Descrição da oferta de emprego

Job ID REQ-10056405

Summary

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

About the Role

Major accountabilities:

• Oversight of all production and testing activities, ensuring compliance with cGxP, including data integrity and eCompliance.
• Support exception investigations.
• Review and approval of production, QC, and Analytical Support (AS) and Testing (T) records.
• Review of Master Batch Records (MBR).
• Support Operational Excellence (OpEx) improvement projects.
• Qualified Person – Executes batch release in compliance with registration.
• Reporting of technical complaints, adverse events, and special case scenarios related to Novartis products within 24 hours of receipt.
• Distribution of marketing samples (where applicable).

Key performance indicators:

• On-time and GMP-compliant release of dosage forms.
• No complaints about inspections by authorities in your area of responsibility without prior notice.
• Support of continuous improvement projects.
• Execution of batch release in compliance with registration.

Skills:

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

Languages:

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