Analista Sênior de Garantia da Qualidade Afiliada (Temporária)

• 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.

• Strong written and verbal communication, interpersonal and teamwork skills, with the ability to prioritize competing tasks and timelines.

As Senior Quality Assurance Analyst, you will support the Quality function within Elanco’s Brazil Marketing Affiliate in São Paulo. You will help ensure that GxP processes and affiliate operations comply with global Elanco standards and applicable local regulations. The role provides quality guidance, reporting and escalation on matters relating to Elanco products distributed in Brazil, while supporting risk reduction and continuous improvement.

• →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 Elanco 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.

Location: São Paulo, Brazil
Work model: Hybrid (3x in the office)

Temporary position: 01 year contract