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Global Quality Auditor So Paulo Sanofi So Paulo

Global Quality Auditor São Paulo

São Paulo STATE OF SãO PAULO
2020-11-17 18:41:29
Global Quality Auditor São Paulo
GLOBAL QUALITY AUDITOR

SAO PAULO

Sanofi is one of the mayor players in the pharmaceutical industry with a proven footprint in Vaccines, Consumer Health Care, and Primary & Specialty Care.

Do you wish to change patient lives? Are you prepared to use your excellent business and people skills? Innovation is part of your way of working? Are you passionate about transformation and leading change?

In this Role

The role ensures that Sanofi Quality and Compliance Standards and applicable Government Regulations are met and that all Sanofi sites and third parties achieve, maintain and improve the current level of compliance through independent auditing and follow-up.

Main Responsibilities:
• Conduct Quality Audits in GxP activities
• Write Audit Reports and review and monitor Corrective/Preventive Action Plans and timelines
• Develop and maintain audit related Global Quality Documents
• Support Regulatory Inspections of Operational Quality Units
• Actively communicate with and support... Operational Quality Units
• Support and participate in training efforts as requested by Operational Units and/or sites, including Pre-Approval Inspection preparation training and Auditor Certification training
• Promote a culture of Ethics and Business Integrity in your team, serving as a model by ensuring adequate knowledge and compliance with the principles of ethics and integrity, Sanofi's policies and codes of conduct that regulate the pharmaceutical market.
• Comply with and promote Sanofi's Health, Safety and Environment (HSE) policies in relation to the team it manages, which includes the Road Safety Program (Road Safety), with the objective of preventing accidents from occurring, avoiding risks for health, promote the well-being of employees and reduce the environmental impacts resulting from the performance of their work activities.
• Support Sanofi's Diversity and Inclusion strategy and initiatives to ensure that all employees and partners are treated with respect and given equal opportunities.
• Your competencies : To succeed in the role, we require candidates to have

Education : Minimum Science Graduate or equivalent

Experience & knowledge: at least +10 years relevant experience in the Pharmaceutical Industry or a major Regulatory Authority

Language: Fluency in written and spoken English required; ability in French, German or Spanish an advantage

Essential Technical Skills:
• Strong technical background in Quality or Production or regulation of Biologics or Vaccines or Combination Products, Medical Devices or Injectable Medicinal Products for Human Use
• Experience in auditing or inspecting regulated healthcare sectors
• Experience in GxP Regulatory Inspections USFDA & EMA
• Advanced knowledge of GxP regulations applicable to Medicinal and Medical Device products for Human Use
• In-depth knowledge of Pharmaceutical Operations
• Advanced knowledge of Computerized System Validation related area

Soft skills:
• Diplomatic
• Inquisitive
• Analytical
• Listening skills
• Flexibility, adaptability
• Communication skills
• Negotiation and Influential skills

Travel requirements:

This position requires approximately 50% travel that may include weekends and Holidays as the business requires

What makes this position unique?

This role provides the opportunity to work in the only internal Quality Audit team in Sanofi, with an auditing scope that covers all GxP activities in the Company. The position gives unrivaled opportunity to work with many different Sanofi facilities /entities across the Sanofi global network

Benefits of working in this role

An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team,

Professional and personal development will be supported purposefully; developing skills and experience in not just auditing but also all Sanofi GxP activities,

Broad experience and skills that come from working in this role are highly transferrable for future career opportunities

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all
São Paulo State of São Paulo Brazil
Global Quality Auditor São Paulo Sanofi São Paulo
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