CSV Validation Lead - GxP @ Square One Resources

Popis pozice

O pozici / o projektu

Původní popisek. You will join a high-performing, globally distributed team working on Basecamp 2.0 , a strategic, breakthrough digital platform within Roche Technical Operations. The initiative aims to significantly reduce technology transfer cycles between Drug Development and manufacturing sites, enabling faster, more reliable, and compliant delivery of life-changing medicines.

This role offers a unique opportunity to contribute to a business-critical innovation recognized by leadership as a key enabler of transformation across the pharmaceutical value chain.

Odpovědnosti

Původní popisek. • Collaborate closely with Product Owners, Scrum Masters, Architects, Developers, Business Owners, and Test Leads

• ▪Define validation strategies and identify required deliverables for GxP computerized systems
• ▪Review software and validation documentation in accordance with corporate CSV SOPs and regulatory requirements
• ▪Estimate and plan validation activities for projects and system enhancements
• ▪Author validation plans, validation reports, and review test documentation for release readiness
• ▪Ensure compliance with corporate quality standards in collaboration with Quality and Informatics teams

Ukázat vše (16) Detail pracovní nabídky

• ▪Ihned
• ▪Práce plně na dálku

Výhody

• ▪Sportovní balíček
• ▪Soukromá zdravotní péče

O firmě