Quality Assurance Specialist

Sanofi; Bardi; On-site; EUR 45,000 - 65,000; Full time

Job summary

Sanofi in Mantova, Lombardia, Italy, seeks a Quality Assurance Specialist to ensure product quality and regulatory compliance across the Manufacturing & Supply network. You will own quality systems, inspections, deviations, and batch release support while driving continuous improvements.

You will coordinate QA activities, review records, and lead training and self-inspection efforts, with 2–5 years of QA/QC experience and a B.Pharm or M.Pharm degree.

Qualifications

• B.Pharm or M.Pharm degree required.
• 2–5 years of QA/QC experience in pharma.
• Experience with IPQA, batch records, and shopfloor governance.

Responsibilities

• Manage and coordinate Quality Systems incl. Product Quality Reviews, Change Control, Deviation, CAPA.
• Oversee QA activities with subcontractors to align with global standards.
• Lead Validation and Calibration document reviews and site master file oversight.
• Support batch release and respond to QP queries with data integrity checks.
• Coordinate cGMP document control, training, and self-inspection.
• Act as Primary Process Owner for Quality Maturity Index and SMS/HSE support.
• Review manufacturing records and logbooks; ensure documentation control.
• Support market complaints investigations and CAPA implementation.
• Perform on-floor quality oversight and in-process QA tasks.

Skills

IPQA

Batch Record Review

Shopfloor Quality Governance

Cross-functional collaboration

Problem-solving orientation

3-shift work availability

Education

B.Pharm or M.Pharm

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 • mantova, lombardia, it