Quality Specialist - Training

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8di3uk

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

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8di3uk