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Global Quality CHC - Auditor - Europe

Synthorx

Synthorx

Quality Assurance
Budapest, Hungary
Posted on Wednesday, May 1, 2024

Global Quality CHC – Auditor – Europe - Sanofi - Budapest

At Sanofi Consumer Healthcare, we have one overarching mission - to work passionately, challenging ourselves and our industry every day, to drive what we believe is the next health revolution: evolving from simply serving consumers, to helping people help themselves - bringing “Health in Your Hands”.

We are building trusted & loved brands that connect with hundreds of millions of consumers worldwide, enabling better self-care for individuals and communities, while also contributing to a healthier planet. To fulfill this mission, we are embarking our consumers, our customers, healthcare professionals, and our employees in this journey because this is what will make us become the “Best Fast-Moving Consumer Healthcare (FMCH) Company In & For the World”.

Consumers at the heart of everything we do and we want to make a difference where it counts, driving leadership in the categories we play in: Allergy, Digestive Wellness, Pain, Physical & Mental Wellness, and Cough, Cold & Flu.

To achieve this, we need strong talent who will help us shape the future of our Consumer Healthcare business and challenge our industry. We aspire to create a work environment where people can thrive, grow, and be at their best every day. We believe in operating with integrity and prioritizing the health and well-being of people and communities where we operate, working towards making a positive impact in the world.

Our Team:

The Opella Healthcare Auditor Lead is a member of the CHC Audits and Inspections team within CHC Global Quality.

The mission of our team is to define the CHC Global Quality Audit policy and to coordinate its implementation across the business and to provide an accurate, independent assessment of CHC sites, Development Centres, country offices, CDMOs and Suppliers for compliance with Sanofi / Opella Quality Policy / requirements and applicable regulations through audit and inspection support activities.

Main responsibilities:

  • Conduct GxP audits (CHC sites, Development Centres, country offices, CDMOs and Suppliers of Active pharmaceutical ingredients, raw Materials, packaging components) mainly in Europe (significant part of the time dedicated to international travels)
  • Support the worldwide auditor’s team as necessary.
  • Prepare audits and issue audit reports in a timely manner.
  • Conduct Global transversal assessment audits.
  • Approve / Manage audit CAPA to agreed timelines.
  • Keep up to date with current and forthcoming regulatory authority requirements, and relevant Sanofi/Opella Global Quality documents. Effectively evaluates compliance with these requirements at Opella entities and third parties and identifies ways for these entities to increase their level of compliance.
  • Together with the Audit lead & Inspection coordinator, support the preparation and follow-up of Regulatory Inspections for GxP activities in the Europe region as required.
  • Support the training and certification of the new Global Quality auditors in the region.
  • Provide expertise on GxP requirements to the entities in the Europe region. Support the local auditors when specific expertise is necessary.
  • Organize communications and Training for the Quality network in the Europe region as necessary.

About you

  • Experience: 10+ years working experience in Quality management and auditing in Pharmaceutical Industry.
  • Technical skills:
    • Good knowledge of GXP regulations and pharmaceuticals standards for a wide range of products (CHC Drug Products, Nutraceuticals, Cosmetics, Medical Devices)
    • Be a qualified auditor, minimum experience of 5 years in a GMP/GDP environment.
    • Ability to make accurate quality evaluations based on multiple data coming from different sources
  • Soft skills: Organization and communication skills, networking capability, leadership and assertiveness skills.
  • Education: Pharmacist or advanced degree (e.g., Master, PhD or equivalent) in life sciences or related fields
  • Languages: English spoken and written compulsory. Speaking French is an asset.

When joining our team, you will experience:

  • An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team
  • An attractive, market-oriented salary and cafeteria benefits
  • Flexible home office policy, with a possibility to work up to 60% of time from home / where you can easily schedule your office days
  • Work from an "Office of the Year 2020" finalist office
  • Collective life and accident insurance
  • Yearly medical check-up
  • An individual and well-structured introduction and training of new employees and we will dedicate a Buddy for you to better navigate in your first weeks
  • Your own career path within Sanofi. Your professional and personal development will be supported purposefully
  • Practice your language skills within our "Language Club"
  • Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs)

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But 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. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability, gender identity or Veteran status.

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

#Sanofi #WeNeverSettle

#SanofiCareers

#PursueProgress

#DiscoverExtraordinary

#joinsanofi

#careerswithpurpose

#SBSBUDAPEST

#LI-EUR

#LI-CHC

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.

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But 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. So, let’s be those people.

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

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But 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. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

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