Analista sr de garantia da qualidade afiliada – São Paulo/SP

Responsabilidades

• Support product quality activities, including product release, assessment of received products, identification of quality or Good Manufacturing Practice (GMP) gaps, and escalation of relevant issues to the Quality Manager.
• Help ensure affiliate operations comply with the Quality Manual, global quality standards, current Good Manufacturing Practice (cGMP) requirements and applicable local regulations.
• Coordinate and maintain quality training activities, affiliate quality documentation and quality metrics, ensuring accurate records and effective communication with stakeholders.
• Support the management of deviations and change controls, including communication, follow-up and approval activities, as well as quality audits, third-party oversight and due diligence.
• Partner with Pharmacovigilance, Customer Complaints and Call Center teams on customer complaints, and support quality activities involving third parties and affiliate audits when required.

Requisitos

• QUALIFICAÇÕES MÍNIMAS
  • Graduation in Science or a related field.
  • At least five years of experience in Quality activities within a regulated environment.
  • Practical knowledge of current Good Manufacturing Practice (cGMP) concepts and their application to quality processes.
  • Analytical and investigative thinking, with the ability to assess quality matters, identify risks and support appropriate escalation.
  • Intermediate English language skills.
• QUALIFICAÇÕES PREFERENCIAIS
  • Strong written and verbal communication, interpersonal and teamwork skills, with the ability to prioritize competing tasks and timelines.

Marcado como: Assuntos Regulatórios, Auditoria, BPF, Controle de Qualidade, Farmacovigilância, Produtos Veterinários