Senior Quality Assurance Analyst - Pharmaceutical Industry

Laboratorios Biopas; Brasília; Presencial; BRL 120.000 - 160.000; Tempo integral

Resumo da oferta

A pharmaceutical company in Brazil is seeking a Senior Quality Assurance Analyst to work on-site. The role involves validation, quality compliance, and experience with GMP regulations. Candidates should have a Bachelor's in Pharmacy or related fields and at least 3 years of industry experience. Strong knowledge of Quality Systems and compliance with ANVISA regulations is required. This position offers an opportunity to work with quality oversight and support audits.

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: 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.

Conhecimentos

Quality Assurance

GMP knowledge

ANVISA regulations

Analytical validation

Deviations investigations

Advanced English

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).