Beschreibung
SAP Project Manager
SAP Project Manager required for Solution Manager contract, starting within the next 3 weeks.
You don't need to be a technical SAP expert, but the following is essential: you will need pharma experience and have some experience or notion of pharma validation, and have experience using Solution Manager as a doc man system
Full spec:
- The consultant will act as project lead plus conceptional work and should be technically competent with the application within a validation environment (but no validation specialist. As the position of the validation manager will be staffed by the CSV department).
- The consultant should also have project management skills.
Some of the project activities the consultant will be required to manage and oversee
Assign Roles to SDLC-Deliverables per Project
Proof of Concept for Validation concept P01 (Global/Local) based on Workshops with Back to Basics/Crossroads platform
Prepare tools decision SolMan as Document Management System (stakeholders/decision makers, requirements, options with pro/cons, costs and timeline)
Evaluate tools to support retrospective Validation (RBE/RWD/SAP Productivity Pack/Record Test Script)
Implement tools to support retrospective Validation (RBE/RWD/SAP Productivity Pack/Record Test Script)
Part 11 compliance for SolMan as Document Management System
Integration with HPQC
Manage BMPL for P01-OTC Spine GxP processes (during project and support/Global/Local) in the DMS
Training of SolMan in SDLC-context for Project Members
General SolMan-URS plus testing of requirements
Contingency for remediation actions going beyond retrospective validation alone
4-System Landscape concept in the context of the new test concept (TDMS, TBOM,)
Write System Management Plan (SMP)
Infrastructure Qualification
4-System Landscape implementation in the context of the new test concept (TDMS, TBOM,)