Quality Assurance Specialist

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
• 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