Quality Assurance Specialist
Pubblicato il 24-10-2026 - Sanofi in Lecce
Quality Assurance Specialist • lecce, puglia, it
In this role you ensure product quality and regulatory compliance within Sanofi’s Manufacturing & Supply network. You will coordinate and own quality systems, inspections, and deviations to support reliable, safe medicines at scale. You’ll interact with cross-functional teams to implement global standards and drive quality improvements. This is a hands‑on position with a focus on end‑to‑end quality governance and continuous improvement, aligned with Sanofi’s mission to deliver life‑changing treatments.
- Manage and coordinate Quality Systems, including Product Quality Reviews, Change Control, Deviation, Market Complaint, OOS/OOT, Training, and CAPA systems
- Coordinate Subcontractor/Service Provider QA activities and ensure alignment with global standards (STDs and GOPs)
- Oversee Validation systems (Process, cleaning, transport, computerized systems) and Calibration document reviews
- Perform batch release support and respond to QP queries; ensure data integrity and audit trail review
- Lead cGMP document control, training coordination, and self‑inspection activities
- Act as Primary Process Owner for Quality Maturity Index (QMI) and support SMS and HSE initiatives
- Oversee Site Master File, instrument checks, and documentation archival/retrieval
- In‑Process Quality Assurance tasks including Master Batch Records review, line clearance, and on‑floor quality oversight
- Temperature/Humidity mapping, hold time studies, and validation/qualification focal points
- HSE adherence, safe working conditions, and zero‑risk safety initiatives
- Review and approve manufacturing records and logbooks; ensure proper documentation control and access management
- Support for Market Complaints investigations and CAPA implementation
- Batch release processing and data integrity related activities
- Quality oversight of shopfloor and routine production sampling
- 2 to 5 years of experience in QA/QC environments
- Experience in IPQA, Batch Record Review, and Shopfloor Quality Governance
- B.Pharm or M.Pharm
- 3‑shift work availability
- cross‑functional collaboration
- problem‑solving orientation
- IPQA
- Batch Record Review
- Shopfloor Quality Governance