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

Efetivo (CLT)

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.

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.