Overview
We have a Contract – Onsite Job opportunity as Technical Project Manager
Job title: Technical Project Manager
Location: Bad Homburg, Germany
Duration: 6 Months • Contract – Onsite
Domain - Pharma - CSV Life Science
Responsibilities
- Develop and document the validation strategy and approach for the Software Development Lifecycle Activities (SDLC) for the global implementation of SAP S4 HANA, considering GxP & Non GxP elements and recommend risk-based testing as required.
- Perform validation service activities related to ECC to SAP S/4 HANA transformation or SAP implementation program.
- Work with Client Q&C to ensure system compliance with internal policies, procedures, guidelines, and applicable health authority regulations; provide improvement plans and revise CSV-related SOPs as necessary.
- Collaborate with project management to build an integrated project plan including the required Computer System Validation (CSV) Lifecycle Deliverables, quality gates and milestone summaries.
- Demonstrate knowledge of SAP workstreams/modules and tools such as Solution Manager, CHARM, SAP GRC, and SAP Rise.
- Apply Lean/Agile approaches to validate assets and manage multiple large projects in dynamic environments.
- Preferably have IT background to understand architecture/technical implications on the program.
- Ensure compliance with Computerized System Validation, 21 CFR Part 11, GxP, GAMP 5, S4, Data Privacy, Data Integrity and Information Security.
Qualifications
- 10-14 years of professional experience in Life Sciences industry in a consulting services organization or industry.
- Strong understanding of pharmaceutical compliance regulations.
- Knowledge of SAP S/4HANA, SAP GRC, SAP Rise; basic functions of SAP workstreams/modules.
- Experience with validation strategy for global SAP S/4HANA implementation; risk-based testing.
- Effective collaboration with stakeholders and ability to handle multiple large projects.
Requirements
- Domain - Pharma - CSV Life Science
- Contract – Onsite