Especialista de garantia da qualidade – São Paulo/SP [híbrido]

SP l São Paulo
Efetivo (CLT)
Biólogo
Bioquímico
Farmacêutico

Responsabilidades

• Lead quality oversight of third-party manufacturers and suppliers across the Americas region, ensuring products are manufactured and released in compliance with current Good Manufacturing Practice (cGMP), local regulations, and a empresa quality standards.
• Review and approve deviation investigations, Corrective and Preventive Actions (CAPA), change controls, complaints, batch documentation, and finished product release documentation.
• Maintain and approve quality procedures, Master Batch Records, and supporting documentation required for regulatory requests and ongoing quality operations.
• Support technology transfers, validation, stability activities, training on quality topics, and cross-functional technical questions from internal teams and external partners.
• Monitor quality performance through Key Performance Indicators (KPIs), self-assessments, and quality plans, and escalate compliance risks and trends to management.

Requisitos

• QUALIFICAÇÕES MÍNIMAS
  • Bachelor’s degree in Pharmacy, Biochemistry, or a related technical discipline.
  • A minimum of 5 years of experience in quality assurance in a Good Manufacturing Practice (GMP)-regulated environment.
  • Hands-on experience with batch release, deviation management, Corrective and Preventive Actions (CAPA), change control, and multi-market quality regulations.
  • Working knowledge of quality systems and tools including Veeva, SAP, and Microsoft Office; intermediate to advanced English proficiency.
• QUALIFICAÇÕES PREFERENCIAIS
  • Spanish proficiency.
  • Experience with technology transfers, validation, and stability studies.
  • Experience managing batch release and documentation with a high level of accuracy and attention to detail.
  • Demonstrated ability to take ownership of new challenges and deliver with urgency in a regulated environment.
  • Proven track record of building strong relationships and delivering customer-focused solutions for internal and external stakeholders.