SAP Project Manager

SKILLS: SAP, PROJECT MANAGEMENT, VALIDATION,GXP,

ROLE: SAP PROJECT MANAGER ( WITH PHARMACEUTICAL SECTOR EXPERIENCE)
LOCATION: ZUCHWIL, SWITZERLAND
DURATION: 2 MONTHS +

JOB DESCRIPTION:

- The consultant will act as project lead/manager 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.
- 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)