Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : 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.
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.