Quality Assurance Specialist

2 giorni fa

La Spezia, Liguria, Italia Sanofi Tempo pieno

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