Senior Quality Assurance Analyst – Pharmaceutical Industry

Há 7 dias


Vargem Grande Paulista, Estado de São Paulo, 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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