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.