CHC - Quality Auditor M/F

Sanofi Winthrop Industrie
Gentilly, France
Competitive salary
17 May 2021
03 Jun 2021
Job role
Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l'international, l'anglais étant la langue de travail.

Key contributions
  • Provides an accurate, independent GMP/GDP/GxP assessment of CHC third parties for compliance with Corporate Quality Policy / requirements and applicable regulations through audit
  • Acts as lead auditor for supplier/Third parties audits
  • Participates actively on the defined auditing program for GMP/GDP/GxP perimeter and ensures that auditing activities are effectively carried out according to the audit strategy
  • Defines his/her annual audit program and manage reporting of audit activities and audit outcomes in timely manner
  • Conducts GMP/GDP/GxP audits worldwide (Significant part of the time dedicated to international travel)
  • Prepares, issues, reviews and approves audit reports in a timely manner
  • Approves/manages audit CAPAs to agreed timelines
  • Performs due diligence activities when requested
  • Contributes to define the GMP/GDP/GxP Quality Audit policy and related quality documentation
  • Participates to ensure an efficient quality management of suppliers and contractors used for manufacturing: distribution products and GxP services through quality audits - Ensure accuracy of Supplier DataBase and related sharepoints - Active participation in the network
  • Manages audit activities subcontracted to external audit partners
  • Assists with the integration of newly acquired entities, including through the performance of baseline audit
  • Participates in qualification training as needed
  • Interacts in the auditor network and directly with Quality Management at Operational Quality Units (external manufacturing, countries , sites )to ensure good governance of the auditing activities, audit findings and related CAPA
  • Contributes to promote and participate on a Quality Assurance Supplier Network to assist in sharing of audit activities, information, identification of best practices and actions on continuous improvement related to audits activities
  • Provides expertise and support for 3rd Parties quality assessment and enhances good practices for process simplification and improvements
  • Actively participates to specific projects of process improvement related to quality management of third parties and to Quality documentation related to raw materials and quality management of third partie
  • Keeps up to date with current and forthcoming GMP/GDP/GxP regulatory authority requirements, and relevant Corporate Quality Documents
  • Contributes on the documentation sharing through erooms and share point

  • Minimum Bachelor's Degree in Science, Science Graduate or equivalent
  • +10 years in Pharma/API industry or a major Regulatory Authority
  • Expertise in:
    • Auditing
    • Manufacturing and Distribution
    • Continuous improvement management
    • Quality risk management
    • Quality systems

  • Advanced Knowledge in GxP and health-related regulations and company requirements, specifically pharmaceutical drug/API Regulations, e.g. FDA/EMA, GxP, ICH. In CHC we will have more and more food supplements, digital applications
  • GxP expertise+
  • Knowledge of IT tools & CS validation
  • Foreign language (English) is a Must
  • Highly independent and compliance mindset
  • Ability to adapt in different cultural situations
  • Easy communication and soft power
  • Strive for results
  • Decisions Making
  • Take actions autonomously
  • Be accountable of his/her decisions
  • Drive a culture of continuous improvement to improve processes and organization effectiveness

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.

As part of its diversity commitment, Sanofi is welcoming and integrating people with disabilities.

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