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
- Required Skillset
- Management (fte and / or contractors)
- The must haves!
- Project Management experience
- (keywords that our recruiters use for their search)
- Need to have strong experience in CSV ERP, Lab Systems, Automation, and Manufacturing
Personality:
- Strong Communication skills, internally and externally to our clients' clients
- Go getter / someone who takes initiative / someone who is proactive
