Quality Assurance Specialist

Sanofi; Lecce; Presencial; EUR 42.000 - 56.000; Jornada completa

Descripción de la vacante

Sanofi is seeking a Quality Assurance Specialist in Lecce, Italy, to ensure product quality and regulatory compliance across the Manufacturing & Supply network. You will coordinate Quality Systems, inspections, deviations, and CAPA to support safe medicines at scale.

The role requires 2–5 years in QA/QC environments, IPQA and Batch Record Review experience, and a B.Pharm or M.Pharm degree. It is a hands-on position with cross-functional collaboration and 3-shift availability.

Formación

• Experience in QA/QC environments.
• IPQA, Batch Record Review, and Shopfloor Quality Governance.
• Experience with cGMP document control and CAPA processes.
• Strong data integrity and audit trail awareness.
• 3-shift work availability and cross-functional collaboration.

Responsabilidades

• Coordinate and own Quality Systems (PQRs, Change Control, Deviation, Market Complaint, OOS/OOT, Training, CAPA).
• Oversee Subcontractor/Service Provider QA activities and ensure alignment with global standards.
• Oversee Validation systems (Process, cleaning, transport, computerized systems) and Calibration reviews.
• Support batch release and respond to QP queries with data integrity review.
• Lead quality governance through document control, training coordination, and self-inspection activities.
• Act as Primary Process Owner for Quality Maturity Index and support SMS/HSE initiatives.
• Oversee Site Master File, instrument checks, and archival/retrieval of documentation.
• Perform In-Process QA tasks including Master Batch Records review and line clearance.
• Conduct Temperature/Humidity mapping, hold time studies, and validation focal points.
• Support Market Complaints investigations and CAPA implementation.

Conocimientos

QA/QC experience

IPQA

Batch Record Review

Shopfloor QA

Quality Systems

Deviations & CAPA

GMP

Cross-functional collaboration

3-shift availability

Educación

B.Pharm or M.Pharm

Descripción del empleo

Quality Assurance Specialist • lecce, puglia, it

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