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CHC Quality Auditor - All Gender

Permanent contract
Gentilly
Salary: Not specified
No remote work

Sanofi
Sanofi

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The position

Job description

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.

CONTEXT

At Sanofi Consumer Healthcare, we have one shared mission – we work passionately, every day, to ‘serve healthier, fuller lives’ now and for the generations to come.

In order to do so, we strive to act as a force for good by integrating sustainability along our business and employees’ mission and operate responsibly from both a social and environmental point of view.

Everything we do is centered around people’s interests – our consumers, our customers, healthcare professionals, and our employees – across the world.

We are building loved brands that serve 1bn consumers worldwide, through our key platforms: Allergy, Physical & Mental Wellness, Pain, Digestive Wellness and Cough, Cold & Flu.

We aspire to become the best Fast Moving Consumer Health (FMCH) company In & For the world and we aim to build a work environment where people can thrive, grow, enjoy and be at their best.

MISSIONS

  • Leads and manages the audits coordination to ensure an efficient quality management of third parties used by CHC
  • Central coordinator for external audits to prospect and select new audits
  • Performs quality audits of key third parties as part of routine management and due diligence
  • Performs quality audits of suppliers of pharmaceutical starting material, drug products and packaging materials on behalf of quality department of CHC entities using these materials
  • Provides direction and support for Sanofi CHC site and Affiliate regulatory inspections

KEY ACTIVITIES

  • Defines and monitors CHC annual quality audit plan and reports the result with dedicated indicators
  • Supports quality audit process implementation
  • Communicates and promotes activities about third parties quality management and audits
  • Supports the qualification of auditors trained or needed to acquire expected knowledge
  • Is a Qualified auditor performing third parties audits with broad scope and focus on Key Third Parties (CMOs)
  • Agile support and guidance in business development opportunities incl. audit execution of Third Parties
  • Provides expertise and support for quality audit management and enhances good practices for process simplification and improvements
  • Ensures the accuracy of the data base for CHC audits and third parties
  • Consolidates key indicators for third parties quality audit and performance status
  • Ensures adequate relationship with other departments as procurement and supply chain and Global Sanofi TP Audit Team
  • Ensures the adequate reporting and actions when risks are identified at third parties level

Role impact

  • The role holder provides a key link between the Sanofi Third Party audits global coordination and the entity’s quality units regarding third parties management
  • The role holder acts as expert and coordinator for the assessment of third parties used by CHC sites
  • Key role for the good practices, monitoring completion and performance of the quality audits annual program through database expert use
  • Transversal role by supporting and tracking audit activities of operational units across the Sanofi CHC organization

Scope

  • Monitoring, tracking and if applicable escalating results for worldwide located quality audits (Contract Manufacturers and Suppliers)
  • Support CHC site audit teams and Affiliates in execution of audits
  • Perform audits for key Third Parties (routine and due diligence)

PROFILE

  • Be a qualified auditor, minimum experience of 10 years in GMP/GDP audits with broad scope (drug products, medical devices, nutraceuticals, cosmetics)
  • 5+ years working experience in Quality management in Pharmaceutical Industry or distribution
  • Good knowledge, background and skills of computerized systems and digital applications
  • Good knowledge in technical environment as of use of databases, extraction models, calculation software
  • Good knowledge of applicable Sanofi CHC global documents and policies related to the Quality Audits
  • Able to travel at least 50%

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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