Quality Assurance Specialist

7 giorni fa

Veneto, 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