Katalyst Healthcares and Life Sciences
Responsibilities:
Responsible for managing end-to-end CSV deliverables for both new & existing applications. Responsible for Implementation of Lab, Enterprise and Manufacturing systems and supporting change management of existing systems. Manage and support CSV Consultants on execution responsibilities & be direct interface to customer FT team. Support Engagement Lead with resource interviews, allocation, utilization, schedule forecasting & adjustments as required. Author the following CSV Deliverables: Initial System Assessment, Functional Specifications, Functional Risk Assessment, Design Documents, SOP Planning, Data Integrity Assessment, Traceability Matrix, protocols (IQ, OQ, PQ), Interim Memo & Validation Summary Report. QA Review of the following CSV Deliverables User Requirements, SOPs Application Administrative Tasks & Protocol Deviation. Requirements:
Management (fte and / or contractors). Project Management experience. Need to have strong experience in CSV ERP, Lab Systems, Automation, and Manufacturing. Strong Communication skills, internally and externally to our clients' clients. Go getter / someone who takes initiative / someone who is proactive.
Responsible for managing end-to-end CSV deliverables for both new & existing applications. Responsible for Implementation of Lab, Enterprise and Manufacturing systems and supporting change management of existing systems. Manage and support CSV Consultants on execution responsibilities & be direct interface to customer FT team. Support Engagement Lead with resource interviews, allocation, utilization, schedule forecasting & adjustments as required. Author the following CSV Deliverables: Initial System Assessment, Functional Specifications, Functional Risk Assessment, Design Documents, SOP Planning, Data Integrity Assessment, Traceability Matrix, protocols (IQ, OQ, PQ), Interim Memo & Validation Summary Report. QA Review of the following CSV Deliverables User Requirements, SOPs Application Administrative Tasks & Protocol Deviation. Requirements:
Management (fte and / or contractors). Project Management experience. Need to have strong experience in CSV ERP, Lab Systems, Automation, and Manufacturing. Strong Communication skills, internally and externally to our clients' clients. Go getter / someone who takes initiative / someone who is proactive.