Quality Assurance Sr Analyst

Sanofi; São Paulo; Presencial; BRL 120.000 - 160.000; Tempo integral

Resumo da oferta

Uma empresa farmacêutica global busca um(a) Analista Sênior de Garantia de Qualidade para supervicionar a qualidade de organizações de fabricação contratadas em São Paulo. O candidato ideal atuará como revisor de qualidade, avaliará processos regulatórios e garantirá a conformidade com as normas GMP. Formado em Farmácia ou área relacionada, com experiência no setor e fluência em Português e inglês. A posição oferece um ambiente de trabalho colaborativo, oportunidades de desenvolvimento de carreira e um pacote de salário competitivo.

Serviços

Oportunidade de trabalhar com tecnologias inovadoras

Pacote de benefícios competitivo

Oportunidades de crescimento de carreira

Qualificações

• Experiência em função de qualidade na fabricação de produtos farmacêuticos.
• Fluente em Português; Inglês Intermediário/Avançado.

Responsabilidades

• Realizar supervisão de qualidade de CMOs e parceiros geridos por EM&S LATAM.
• Ser o principal revisor de qualidade de eventos como desvios e reclamações.
• Realizar avaliações científicas e regulatórias dos processos GMP.
• Contribuir para a manutenção do sistema de qualidade EM&S LATAM.

Conhecimentos

Excelentes habilidades de comunicação

Habilidades organizacionais

Formação académica

Bacharel em Ciências (preferencialmente Farmacêutico)

Descrição da oferta de emprego

About the job

Quality Assurance Senior Analyst (Analista Sênior de Garantia de Qualidade) – Location: São Paulo, BR (Parque da Cidade).

The EM&S (External Manufacturing and Supply) LATAM QA Analyst performs direct quality oversight of Contract Manufacturing Organizations (CMOs) managed by the hub to ensure that manufacturing operations are conducted in compliance with GMPs and the quality agreement in place. The position is the direct contact with CMOs for quality matters and also interacts with functional units of EM&S LATAM, affiliate functions, M&S sites, and other Sanofi organizations.

Key responsibilities include contributing to the establishment and maintenance of the EM&S LATAM Quality System, ensuring optimal proximity with CMOs, and building strong relationships with partners.

Responsibilities

• Perform quality oversight of CMOs and partners (licensors) managed by EM&S LATAM by monitoring CMO compliance via GMP documentation review, remote contacts, and onsite visits/audits.
• Be the primary quality reviewer of events such as change controls, deviations, and complaints, including associated investigations and CAPAs.
• Perform scientific, quality, and regulatory assessments of portfolio-related GMP processes (manufacturing processes, validations, stabilities, etc.) to provide a Sanofi standpoint.
• Complete or assess product quality reviews according to established quality agreements.
• Lead CMO quality reviews.
• Contribute to the CMO quality risk ranking assessment and lead associated mitigation initiatives.
• Support country quality organizations where EM LATAM portfolio is supplied, sharing relevant product information.
• Contribute to the design and maintenance of quality agreements with partner quality units.
• Participate in new CMOs qualification initiatives, including initial assessment, due diligence, audit assessments, and Quality Agreement definition.
• Perform quality oversight of material suppliers and service providers.
• Identify and communicate potential or confirmed critical quality events to management to ensure rapid escalation.
• Implement and maintain the hub QMS by designing and maintaining different quality systems.
• Define and lead the entity third-party audit program, including scheduling, audit outcome assessment, and follow-up of action plans.
• Work following approved procedures and predefined goals as a member of the EM&S LATAM team.
• Maintain a positive work atmosphere by promoting cooperation with third parties, internal customers, collaborators, co-workers, and management.

About you

• Education: Bachelor of Science degree (Pharmacist preferred).
• Experience: Quality role in pharmaceutical manufacturing.
• Skills: Excellent communication and organizational skills.
• Languages: Fluent Portuguese; Intermediate/Advanced English.

Why choose us

• Opportunity to work with cutting‑edge technologies in a global pharmaceutical leader.
• Collaborative and innovative work environment.
• Career growth and development opportunities.
• Competitive salary and benefits package.

Progress

Progress doesn’t happen without people – diverse backgrounds, different locations, and roles united by a desire to make miracles happen.

Chasing change, embracing new ideas, and exploring all opportunities.

Let’s pursue progress and discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.