Project Assistant: Documentation Support, Inventory Monitoring, SAP support, and Purchase Order Processing Project Title: Manufacturing Document Management, Procurement Documentation Tracking, and SAP Support
Project Overview: This Statement of Work (SOW) outlines the Product of services and deliverables for manufacturing document management, procurement documentation tracking, and SAP support for various projects. The project involves several administrative tasks, document management activities, and SAP-related support. The primary objectives include assisting document creation, routing documents for approval, SAP item code set up, Bill of Materials (BOM) creation activities, inventory monitoring, database management, purchase order processing, and deviation management.
Project Product: - Document Routing and Approval:
- Submit CT Manufacturing team documents to document controllers for routing within the organization.
1. Uploading CT Tech Rep-authored documents into Veeva Vault (QDocs) database (Analytical Results, Pre- and Post- batch checklists, etc.)
2. Route CT Tech Rep-authored documents for review and approval
Facilitate document approval workflows and ensure timely responses.
Maintain detailed records of document status and approvals.
- Manufacturing Document Management:
- Help initiate composition, facilitate review, and editing phases of manufacturing documents under guidance of Clinical Trial Manufacturing Representatives.
1. MANF and other project-specific Document Support
2. RIM database historical searches
- Research and include appropriate references in the documents.
- Route documents for approval following established protocols.
- Upload documents into the database and ensure proper categorization.
- Deviation Management:
- Upload internal and external deviations into the database.
1. Uploading external deviations to Trackwise, route, and monitor for approval.
- Route deviations and ICIs for internal approval processes.
- Monitor the status of deviation approvals and follow up with email reminders and planned meetings as necessary with key stakeholders (CT Manufacturing Tech Rep, Quality Assurance Rep, project management, functional management) to finalize decisions and reach approval
Inventory Monitoring: - Monitor the movement of inventory related to clinical trial batches.
- Help track storage costs, manage what materials availability, facilitate material shipping with CT Operations team.
- Ensure timely and accurate shipments to partner locations with CT Materials Management team.
- Monitor and follow inventory for CT batches (ex. Excipients that shop from Lilly to CMO)
5.SAP Support: - Create new item codes in SAP for manufacturing purposes.
- Develop Bill of Materials (BOM) in SAP for new items.
- Monitor and follow up on the status of SAP item code and BOM requests.
6. Purchase Order Processing: - Utilize an approved quote to set up purchase orders in the database.
1.Set up the PO in Ariba/Guided Buying and route for approval
- Route purchase orders for necessary approvals within the organization.
- Ensure adherence to procurement policies and guidelines.
- Maintain consistency on team inputs for IO number, quotes (Cost of proposals), add additional miscellaneous expenses, ensure revised POs attach a change of Product
- Send CT Manufacturing Leadership concise messaging (following template email) that an approval is needed
- Assist CT Manufacturing Tech Reps in staying on top of invoices; make sure to follow and monitor remaining balance on a PO (following up with Procurement and CT Manufacturing Tech Reps on urgent actions).
Project Deliverables:
- Manufacturing documents drafted, researched, and edited as required.
- Document records uploaded and routed for review and approval.
- Deviations uploaded, routed, and monitored for approval.
- Inventory monitoring reports for clinical trial batches.
- SAP item codes and BOMs created and tracked.
- Purchase orders set up and routed for approval.
Project Timeline: The project is expected to commence NLT 01Dec2023 and conclude on a future date to be agreed. This timeline may be subject to adjustments based on the complexity of tasks and organizational requirements.
Project Team: The following functions will be involved in the project:
- CT Tech Rep
- Plant Planners
- Material Coordinators
- Quality Assurance Representatives
- Document Controllers
- SAP Administrator
- Inventory Management Team
- Database Administrator
- Procurement Team
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Last updated on Nov 22, 2023