@Lilly MQ strives to enable the making of medicine “with safety first and quality always”. The CSV Lead will provide... CSV related audits and privacy related inspections, working in collaboration with Computer Systems Quality Assurance...
Job Description: Demonstratable Experience in Computer System Validation (CSV) Experience in software development... documents (CSV), including Compliance Analysis, Compliance Plan, Change Control Document, User & Functional Requirement...
automation systems tailored to regulated environments. We are seeking a Senior Validation Engineer – Project Lead... policies and procedures. Lead and participate in Design Reviews with cross functional teams in including equipment...
) preferred. Strong understanding of GMP, regulatory requirements, and computer system validation (CSV) principles. Excellent...
of supporting future technologies like continuous manufacturing and single-use systems. Strategic Process Optimization: Lead... standards and design patterns for MES/LES development, aligned with industry frameworks like GAMP 5. Act as the lead mentor...
, reducing average times and boosting trading partner satisfaction through efficient functional designs Lead functional aspects..., integration best practices, and B2B/B2C operations, including: Standards & Formats: ANSI X12, XML, JSON, SAP iDoc, and CSV...
consulting and interpretation of policies and procedures, providing oversight for computer systems validation (CSV) and platform... areas are appropriately tracked in CAPA plans. Participate in and/or lead self-inspections, audits, and supplier...
in a regulated (GxP) environment. Lead OT system qualification and validation, including Client/DCS integrated with manufacturing... of relevant experience in CSV/IT Quality & Compliance within the Life Sciences industry. Expertise in OT system qualification...