Quality assurance sr analyst – São Paulo/SP

Responsabilities

• Monitor CMO compliance via GMP documentation review, remote contacts and onsite visits/  audits. He/ she is the primary quality reviewer of events as change controls, deviations and complaints, including asociated investigations and CAPAs.
• Perform sound scientific, quality and regulatory assessments of portfolio related GMP processes (manufacturing processes, validations, stabilities, etc) to provide the CMOs a Sanofi  position.
• Complete or assess, according to established quality agreements, product quality reviews
• Leads CMO quality reviews
• Contributes to the CMO quality risk ranking establishment and leads associated mitigation initiatives Support country quality units completing product market release of EM Brazil supplied portfolio, ensuring key information is available to ensure their compliant distribution.
• Contribute to the design and maintenance of quality agreements established with their quality units.
• Participate in CMOs qualification initiatives, including initial assessment, due diligences, audit process and establishment Quality Agreements.
• Perform quality oversight of material suppliers and GMP service providers.  Identify and communicate potential or confirmed critical quality events to management to ensure rapid escalation.
• Contribute to the implementation and maintenance of the hub QMS (Quality Management System) by design and maintenance to different quality systems.
• Define and lead the entity third parties audit program including scheduling, audit team member selection, audit outcome assessment and follow up of plans of action.
• As a member of EM&S LATAM team, work following approved procedures and as per predefined goals.
• Maintain a positive work atmosphere by acting and communicating in a manner that promotes cooperation with third parties, internal customers, collaborators, co-workers and management.

Requirements

• 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.

Marcado como: Indústria Farmacêutica, Qualidade