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Senior Quality Assurance Analyst – Pharmaceutical Industry

4 semanas atrás

Vargem Grande Paulista, Brasil Laboratorios Biopas Tempo inteiro

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).