Senior Quality Assurance Analyst – Pharmaceutical Industry

Laboratorios Biopas; São Paulo; Presencial; BRL 120.000 - 160.000; Tempo integral

Resumo da oferta

A leading pharmaceutical company in São Paulo is seeking a Senior Quality Assurance Analyst to ensure compliance with GMP and ANVISA regulations. The role involves managing quality systems, conducting investigations, and supporting audits. Candidates must have a Bachelor's degree in relevant fields and at least 3 years of experience in Quality Assurance. Strong knowledge of Quality Management Tools and advanced English skills are essential for success in this role.

Qualificações

• Minimum of 3 years of experience in Quality Assurance within the pharmaceutical industry.
• Strong knowledge of GMP and ANVISA regulations.
• Knowledge of Quality Systems.

Responsabilidades

• Support technology transfer strategies and analytical validation activities.
• Review and approve documents related to validation and qualification.
• Prepare and review Quality System documents.
• Conduct deviation investigations.
• Ensure compliance with GMP and ANVISA regulations.
• Perform finished product release, ensuring compliance with specifications.
• Support internal and external audits.

Conhecimentos

GMP Knowledge

Quality Management Tools

Analytical Validation

English (Advanced)

Formação académica

Bachelor's degree in Pharmacy, Chemistry, Biomedicine, or related fields

Descrição da oferta de emprego

Position

Senior Quality Assurance Analyst – Pharmaceutical Industry

Location

Vargem Grande Paulista, São Paulo, Brazil

Work Model

100% On-site

Position Description

We are seeking a Senior Quality Assurance Analyst to work on‑site at our facilities, with a primary focus on Validation / Qualification, Quality, and Compliance.

• The ideal candidate will have prior experience preparing and reviewing Quality procedures and policies, equipment qualification, analytical validation, Good Manufacturing Practices / Good Laboratory Practices, documentation, Quality Oversight, deviation investigations, CAPA, and Change Control.

This position is ideal for professionals with solid experience in the pharmaceutical industry and in depth knowledge of GMP, Equipment Qualification, and Quality Management tools.

Responsibilities

Support technology transfer strategies and analytical validation activities.

Review and approve documents related to validation and qualification.

Prepare and review Quality System documents: protocols, reports, SOPs, and quality records.

Conduct deviation investigations.

Ensure compliance with GMP, Good Laboratory Practices, and ANVISA regulations.

Perform finished product release, ensuring compliance with specifications and regulatory requirements.

Support internal and external audits, as well as health authority inspections.

Manage controlled substances according to RDC 344 (monthly and quarterly reports).

Requirements

Bachelor's degree in Pharmacy, Chemistry, Biomedicine, or related fields.

Minimum of 3 years of experience in Quality Assurance within the pharmaceutical industry.

Strong knowledge of GMP and ANVISA regulations.

Knowledge of Quality Systems.

Previous experience in Quality Control is a plus.

Knowledge of Equipment Qualification and Maintenance.

Advanced English (reading, writing, and technical communication).