Global Quality CHC – Auditor – America Locations: Bogota Time Type: Full time Posted on: Posted 3 Days Ago Time left to apply: End Date: November 29, 2024 (18 days left to apply) Job Requisition ID: R2767416 About the job 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. At Sanofi Consumer Healthcare, we have one overarching mission - to work passionately, challenging ourselves and our industry every day, to build a healthier future by helping people, help themselves, bringing "Health in Your Hands". Main responsibilities: Conduct GxP audits (CHC sites, Development Centres, country offices, CDMOs and Suppliers of Active pharmaceutical ingredients, raw Materials, packaging components) mainly in North & South Americas (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 evaluate compliance with these requirements at Opella entities and third parties and identify 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 Americas region as required. Support the training and certification of the Global Quality auditors in the region. Provide expertise on GxP requirements to the entities in the Americas region. Support the local auditors when specific expertise is necessary. Organize communications and training for the Quality network in the Americas region as necessary. About you Experience: 10+ years working experience in Quality management and auditing in Pharmaceutical Industry. International experience being audited and conducting audits in the pharmaceutical human consumption 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 Spanish is an asset. Why choose us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Play an instrumental part in creating best practice within our manufacturing facility. #J-18808-Ljbffr