CSV Lead (Managed Services

Job Title

Responsible for managing end-to-end CSV deliverables for both new and existing applications.

Responsibilities:

• Implementation of Lab, Enterprise and Manufacturing systems and supporting change management of existing systems.
• Manage and support CSV Consultants on execution responsibilities and be direct interface to customer FT team.
• Support Engagement Lead with resource interviews, allocation, utilization, schedule forecasting and 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)
• Project Management experience
• 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