Quality Assurance Sr Analyst

4 semanas atrás

São Paulo, Brasil buscojobs Brasil Tempo inteiro

Overview

Quality Assurance Sr Analyst

The EM&S Brazil QA Analyst performs direct quality oversight of Contract Manufacturing Organizations (CMOs) managed by the hub to ensure that manufacturing operations are conducted in accordance with GMPs and the quality agreement in place. The position is the direct contact with CMOs for quality matters and collaborates with EM&S LATAM, Brazil affiliate functions, M&S sites, and other Sanofi organizations to support quality systems and continuous improvement.

EM&S is a consolidated organization managing outsourced Sanofi products, operating in regions through virtual sites to ensure proximity with CMOs. The role engages in network optimization and builds strong relationships with partners. It contributes to expanding industrial limits in installed capacity and technology to guarantee quality, regulatory compliance, customer service, and cost effectiveness, following internal compliance guidance.

Main responsibilities
  • Monitor CMO compliance via GMP documentation review, remote contacts, and onsite visits/audits. Serve as the primary quality reviewer of events such as change controls, deviations and complaints, including associated investigations and CAPAs.
  • Perform sound scientific, quality, and regulatory assessments of GMP processes (manufacturing processes, validations, stabilities, etc.) to provide the CMOs with a Sanofi position.
  • Complete or assess product quality reviews according to established quality agreements.
  • Lead CMO quality reviews and contribute to CMO quality risk ranking with mitigation initiatives.
  • Support country quality units in completing product market releases of EM Brazil supplied portfolio; ensure key information is available for compliant distribution. Design and maintain quality agreements with quality units. Participate in CMOs qualification initiatives, including initial assessment, due diligence, audit processes, and establishment of Quality Agreements. Perform quality oversight of material suppliers and GMP service providers. Identify and communicate potential or confirmed critical quality events to management for rapid escalation.
  • Contribute to the implementation and maintenance of the hub Quality Management System (QMS) and quality systems across sites. Define and lead the entity third-party audit program, including scheduling, audit team selection, audit outcome assessment, and follow-up of actions.
  • As a member of the EM&S LATAM team, follow approved procedures and predefined goals; maintain a positive, collaborative work environment with third parties, internal customers, collaborators, co-workers, and management.
  • Maintain knowledge of and comply with Ethics and Integrity principles, Sanofi policies, and codes of conduct governing the pharmaceutical market.
  • Comply with Sanofi Health, Safety and Environment (HSE) policies to prevent accidents, manage health risks, promote well-being, and reduce environmental impact related to work activities.
Qualifications
  • Education: Bachelor of Science degree; Pharmacist preferred.
  • Experience: in a quality role in pharmaceuticals manufacturing.
  • Skills: Excellent communication and organizational skills.
  • Languages: Fluent Portuguese and intermediate/advanced English. Spanish is a plus.

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.

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