and participate in CSV lifecycle activities for GxP systems (e.g., SAP, TrackWise, Veeva, etc.) including risk assessments, validation... computerized systems and US product distribution, including batch release, labeling, artwork approvals, and related quality system...
monitoring and sampling, assays, specification setting), Supply Chain and Warehouse Management, Validation, and Quality Systems... with pharmaceutical manufacturing processes, including equipment, utilities, and facilities, cGMP compliance, high purity water systems...
developing integrations with Veeva, Documentum, Calyx/Ennov RIM, Integra’s, and Lorenz systems. Knowledge of global regulatory... and the Veeva RIM platform. The role encompasses end-to-end development, configuration, and maintenance of integrations...
. Understanding of quality management systems. Knowledge of applicable business systems including SAP, LIMS, Maximo and Veeva Vault... operations of the Devens Cell Therapy Facility, including commissioning, qualification, and validation (CQV), computer systems...
within targeted institutions and systems Develops a deep understanding of the institutional customer, account & market dynamics... to leverage existing institutional relationships Proven ability to navigate hospital institutions and systems and engage...
). Proficiency in Microsoft Office Suite and documentation systems such as Veeva or MasterControl. Strong analytical and problem... systems. Define process-relevant calibration requirements and ensure equipment remains fit for intended use. Support...
, deviations, in-process data, EM data, QC release and stability testing and other quality systems documentation... of executed batch and/or critical systems documentation including certificate of analysis / certificate of conformance...
recovery systems, associated supply and waste tanks, and air emissions systems. The Supervisor is the management representative... to support the project delivery, build a new organization, develop and implement the necessary systems and business processes...
management systems (e.g., Trackwise. Veeva, QualityDocs, Kneat) Lilly is dedicated to helping individuals with disabilities... employees. Managing a contractor safety program across a large footprint. Implementation of electronic permit to work systems...
, and training documentation. Facility, Equipment, Systems Start-up Equipment design, qualification, and process validation.... Manufacturing Execution Systems and electronic batch release. Automated Storage and Retrieval System (ASRS) Warehouses or AGVs...