Global Quality CHC – Auditor – AMEA
Sanofi
- Hyderabad, Telangana
- Permanent
- Full-time
- Location Hyderabad
- Job type: Permanent
- Conduct GxP audits (CHC sites, Development Centres, country offices, CDMOs and Suppliers of Active pharmaceutical ingredients, raw Materials, packaging components) mainly in AMEA (Africa, Middle East, Asia) region. A significant part of the time is 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 AMEA 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 AMEA region. Support the local auditors when specific expertise is necessary.
- Organize communications and Training for the Quality network in the AMEA region as necessary.