Quality Assurance Specialist

5 ore fa

Latina, Lazio, Italia Sanofi Tempo pieno

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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

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