Quality Assurance Lead for End-to-End GMP Compliance

Sanofi; Lecce; Sur place; EUR 42 000 - 56 000; Plein temps

Résumé du poste

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.

Qualifications

• 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.

Responsabilités

• 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.

Connaissances

QA/QC experience

IPQA

Batch Record Review

Shopfloor QA

Quality Systems

Deviations & CAPA

GMP

Cross-functional collaboration

3-shift availability

Formation

B.Pharm or M.Pharm

Description du poste

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.