Senior Validation Consultant

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.

Required Skillset:

Management (FTE and / or contractors).
Project Management experience.
Need to have strong experience in CSV ERP, Lab Systems, Automation, and Manufacturing.

Personality:

Strong Communication skills, internally and externally to our clients.
Go getter / someone who takes initiative / someone who is proactive.