Overview 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.

Responsabilità

- 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

Requisiti fondamentali
- 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
- Languages: English, Hindi, Konkani, Marathi
- 3-shift work availability
- attention to detail
- cross-functional collaboration
- problem-solving orientation
- IPQA
- Batch Record Review
- Shopfloor Quality Governance

📌 Quality Assurance Specialist (Siena)
🏢 Sanofi
📍 Siena