Awadh Raj Singh

Validation Lead @Novo Nordisk

Bengaluru, IN

Led validation projects for multiple GxP-regulated systems (CTMS, Veeva Vault QMS, eTMF, Artwork and Label Management), ensuring compliance with global regulatory standards-Directed validation lifecycle deliverables including URS, FRS, Traceability Matrix, and Test Scripts in accordance with CSV/CSA best practices-Oversaw IQ, OQ, PQ documentation, testing coordination, periodic reviews, and deviation management- Improved audit readiness by preparing compliance checklists, ensuring 100% audit success- Collaborate with program managers, product owners, engineers (Dev and QA), architects, and other cross-functional teams for successful release delivery- Utilized ADO tool to create and manage user stories, tasks, and bugs, while maintaining and prioritizing the backlog for multiple GxP-regulated systems- Reviewed suppliers on multiple parameters including IT security, organizational culture, QMS, and business requirements- Delivered CSV training sessions to improve organizational compliance culture and team efficiency- Led a team of 5 to successfully deliver a complex GxP project involving new interface integration and server migration-

Bharati vidyapeeth college of engineering

Bachelor of Technology - BTech