Role OverviewWe are looking for a Principal– SAP Computerized System Validation (CSV) to lead Computerized System Validation (CSV) activities for SAP ECC to SAP S/4HANA transformation programs and new SAP implementations. The candidate will have to perform validation service activities related to ECC to SAP S/4 HANA transformation or SAP implementation program.
What You Will Do
The candidate will lead CSV activities, develop and execute validation strategies, plans, protocols, and reports for GxP and non-GxP systems, and ensure validation activities comply with regulatory and company quality requirements.
Why It Might Be a Fit
The ideal candidate will have a strong understanding of pharmaceutical compliance regulations and validation concepts, experience with Agile and Waterfall methodologies, and excellent communication and collaboration skills.
Requirements
- Minimum of 12+ years of professional experience in Life Sciences industry working for a consulting services organization and/or industry experience.
- Experience creating, reviewing and approving / acknowledging validation deliverables.
- Knowledge of risk management process and quality management requirements which assures that IT Projects meet Quality and Regulatory requirements
- Understanding of key pharmaceutical compliance regulations like Computerized System Validation, 21 CFR Part 11, GxP, GAMP 5, SOX IT, Cloud, S4, Data Privacy, Data Integrity and Information Security
- Experience with Agile and Waterfall methodologies.
- Familiarity with tools like ServiceNow, JIRA, Veeva, HPALM.
- Ability to manage multiple projects and adapt to complex environments.
- IT background preferred to understand program complexities.
- Excellent communication and collaboration skills.
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