What are the responsibilities and job description for the CSV Lead position at Katalyst Healthcares & Life Sciences?
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.
