Technical Project Manager
vor 2 Wochen
Greetings From Ampstek
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
If interested, kindly share your CV at
Domain - Pharma -CSV Life Science
Job Description
We are looking for people who have demonstrated proven success in roles and through abilities in
Computerized System Validation for ERP applications like ECC/SAP S/4 HANA
, Risk management and Quality Management. The candidate will have to perform validation service activities related to ECC to SAP S/4 HANA transformation or SAP implementation program.
- 10-14 yrs of professional experience in Life Sciences industry working for a consulting services organization and/or industry experience.
- Understanding of key pharmaceutical compliance regulations like Computerized System Validation, 21 CFR Part 11, GxP, GAMP 5, S4, Data Privacy, Data Integrity and Information Security
- 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 for risk-based testing approach as required.
- Work with Client Q&C to ensure system compliance with internal policies, procedures, guidelines, and applicable health authority regulations and provide improvement plans to streamline practices, and revise CSV related SOPs as necessary.
- Work with project management to build an integrated project plan inclusive of the required Computer System Validation (CSV) Lifecycle Deliverables, quality gates and summarization milestones.
- Knowledge on basic functions on SAP workstreams/modules
- Knowledge of various tools/applications used in SAP implementation programs such as Solution Manager, CHARM, SAP GRC, and SAP Rise
- Successful track record using Lean/Agile approaches to validate assets
- Proven ability in handling multiple large projects, respond quickly to changing situations in complex environments
- Preferable IT background to understand larger impact of architecture / technical complexities on the program
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