Quality Assurance Specialist
Pubblicato il 09-10-2026 - Sanofi in Bologna
Overview
In this role, you will safeguard product quality across QA systems and GMP processes at the Goa site.
You will collaborate with cross-functional teams to manage quality reviews, deviations, CAPAs, and validation activities, ensuring compliance with ICH/GxP standards.
Your work supports fast, safe delivery of life-changing medicines at scale.
This position offers a hands-on role in quality governance within a global biopharma network, leveraging data and processes to improve compliance and product quality.
You will be a focal point for IPQA, change controls, and QA oversight on the shop floor, enabling reliable batch release and continuous improvement.
Responsabilità
Manage Quality Systems including Product Quality Reviews, Change Control, Deviation, Market Complaint investigations, and CAPA.
Act as QA focal point for OOS/OOT management and ICHQ3D requirements.
Coordinate implementation of Sanofi Global Standards (STDs) and Global Operating Procedures (GOPs).
Oversee Subcontractor/Service Provider management and various validation systems (process,
cleaning, transport, computerized systems).
Support training, document control, data integrity, audit trails, and archival/retrieval.
Lead batch release activities and respond to QP queries; manage Master/Batch Records review and line clearance.
Participate in self-inspections, GMP training, and cGMP documentation review.
Act as Site Master File custodian and support HSE activities and SMS initiatives.
Oversee Calibration document reviews and user access management; support nitrosamine assessment and QA studies.
Coordinate IPQA activities including in-process checks, sampling, and shopfloor quality oversight.
Requisiti fondamentali
2 to 5 years of experience
B.Pharm / M.Pharm
Experience in IPQA, Batch Record Review, and Shopfloor Quality Governance
cross-functional collaboration
attention to detail
strong communication
IPQA
Batch Record Review
GxP document review