Quality Assurance Sr Analyst  

Quality Assurance Sr Analyst  

• Location: São Paulo (SP) – sede
• Prazo Determinado (6 meses)

About the job

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. Also, the position interacts within functional units of EM&S LATAM, Brazil affiliate functions and M&S sites, but also other organizations within Sanofi.

The QA Analyst also contributes to the establishment and continuous improvement of EM&S LATAM Quality System on specific domains, providing support for implementation and management of the quality systems.

EM&S is a consolidated organization managing outsourced Sanofi products, which​ operates in each region through virtual sites 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 Brazil by:

- 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.

• Maintain knowledge of and comply with the principles of Ethics and Integrity, Sanofi policies and codes of conduct that regulate the pharmaceutical market.

• Comply with and promote Sanofi Health, Safety and Environment (HSE) policies, with the aim of preventing accidents, avoiding health risks, promoting employee well-being and reducing environmental impacts resulting from the execution of work activities.

• Support Sanofi Diversity & Inclusion strategy and initiatives to ensure all employees and partners are treated with respect and receive equal opportunities.

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. Spanish is a plus.

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

PursueProgress. Discover Extraordinary.

Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s 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.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Attention to the Phrases Below

*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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