Quality Assurance Specialist

Sanofi; Trieste/Trst; On-site; EUR 47,000 - 68,000; Full time

Job summary

Sanofi in Trieste, Friuli Venezia Giulia, Italy seeks a Quality Assurance Specialist to ensure product quality and regulatory compliance across the Manufacturing & Supply network. The role focuses on end-to-end quality governance, CAPA, and continuous improvement in line with Sanofi’s mission to deliver safe medicines.

The candidate will manage Quality Systems, coordinate QA activities with external providers, and lead document control, change control, and training.

Qualifications

• 2–5 years of experience in QA/QC environments.
• Experience in IPQA, Batch Record Review, and Shopfloor Quality Governance.
• Bachelor or higher in pharmaceutical sciences or related field.

Responsibilities

• 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
• 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

Skills

QA/QC experience

IPQA

Batch Record Review

Shopfloor Quality Governance

Cross-functional collaboration

Problem-solving

Education

B.Pharm or M.Pharm

Tools

Quality Management Systems

CAPA

Change Control

Deviation handling

Job description

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
• 3-shift work availability
• cross-functional collaboration
• problem-solving orientation
• IPQA
• Batch Record Review
• Shopfloor Quality Governance

Quality Assurance Specialist • trieste, friuli venezia giulia, it