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
📌 Quality Assurance Specialist (Italia)
🏢 Sanofi
📍 Italia