What are the responsibilities and job description for the Senior Validation Consultant position at Katalyst Healthcares & 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.
- 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.
- User Requirements, SOPs Application.
- Administrative Tasks & Protocol Deviation.
- 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.
- Go getter / someone who takes initiative / someone who is proactive.
