Senior Quality Assurance Analyst

1 semana atrás

Propriá, 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).

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