Quality Assurance Specialist

Sanofi; Pescara; Sur place; EUR 55 000 - 75 000; Plein temps

Résumé du poste

Sanofi in Pescara, Abruzzo, Italy, is seeking a Quality Assurance Specialist to ensure product quality and regulatory compliance across the manufacturing network. You will own QA systems, conduct investigations, and drive continuous improvement while ensuring data integrity and proper documentation.

Applicants should have 2–5 years in QA/QC environments, IPQA and batch record experience, and a B.Pharm or M.Pharm. The role requires 3-shift availability and strong cross-functional collaboration.

Qualifications

• Must have hands-on QA/QC experience in pharma.
• Experience with IPQA, batch records, and shopfloor governance.
• Knowledge of cGMP and quality systems is required.

Responsabilités

• Coordinate and own quality systems, inspections, and deviations.
• Oversee Calibration, validation, and document reviews.
• Lead site master file review and on-floor quality oversight.
• Support market complaints investigations and CAPA implementation.
• Perform batch release support and QP data review.

Connaissances

Cross-functional collaboration

Problem-solving orientation

IPQA

Batch Record Review

Shopfloor Quality Governance

Formation

B.Pharm or M.Pharm

Outils

Quality Systems

cGMP documentation

Description du poste

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 pescara, abruzzo, it