Quality Assurance Sr Analyst (Analista Sênior de Garantia de Qualidade)
Location: BR / Sao Paulo / Parque da Cidade
About the job
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. It also interacts within functional units of EM&S LATAM, affiliate functions and M&S sites, but also other organizations within Sanofi.
The QA Analyst also contributes to the establishment and maintenance of EM&S LATAM Quality System on specific domains.
EM&S is a consolidated global organization managing outsourced Sanofi products, operating in different locations ensuring optimal proximity with CMOs, engaged in a network optimization and building a strong relationship with our partners.
We extend Industrial Sanofi Limits, in both, installed capacity and technologies guaranteeing successful and sustainable results in terms of Quality & Regulatory compliance, Customer Service and Cost, through strong tactical principles and following internal compliance guidance.
Main responsibilities
Performs quality oversight of CMOs and partners (licensors) managed by EM&S LATAM by:
Monitor CMO compliance via GMP documentation review, remote contacts and onsite visits/ audits. 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 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
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 established with their quality units.
Participate in new CMOs qualification initiatives, including initial assessment, due diligences, audit assessments and Quality Agreements 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.
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 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.
About you
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.
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
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*Always aimed at the safety and well-being of our employees, proof of COVID-19 vaccination is an essential item for all employees, being present on the list of admission documents.
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