| SAP GXP Lead/Architect at Remote, Remote, USA |
| Email: [email protected] |
| SAP GXP Lead/Architect Location: Chicago Onsite This role is actively involved in ensuring that SAP Systems implemented and managed by Astellas IS comply with regulations (GxP) Policies and Standards Essential Job Responsibilities:Risk & ComplianceDevelop a global SAP Compliance team and provide compliance leadership to project and BAU change teams implementing and maintaining SAP systems This includes overseeing interim R&C resources who review and approve SLC deliverables Job Requirements: Proven experience in the qualification and validation of ERP platforms, specifically SAP, within a regulated environment Demonstrated ability to lead validation strategy, planning, and execution for complex SAP implementations, ensuring successful delivery and compliance Strong collaboration skills with the ability to work effectively with cross-functional teams and stakeholders to establish and meet validation requirements and timelines Expertise in developing and maintaining comprehensive validation and compliance documentation, with a keen attention to detail and accuracy In-depth knowledge of GxP regulations and guidelines, including FDA 21 CFR part 11, GAMP 5, and the ability to apply these standards to ensure system integrity and regulatory compliance Long Term Job Responsibilities: Lead the qualification and validation processes for ERP platforms, with a focus on SAP, ensuring that all systems meet industry standards and regulatory requirements Develop and execute a comprehensive validation strategy and plan for SAP implementations, coordinating with project teams to align timelines and deliverables Collaborate with cross-functional teams, including IT, Quality Assurance, and business stakeholders, to define validation requirements and ensure that all aspects of the system are thoroughly tested and compliant Create and maintain essential validation documentation, such as requirements specifications, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) protocols, test scripts, and traceability matrices Stay current with GxP regulations and guidelines, including FDA 21 CFR part 11, GAMP 5, and other relevant standards, to ensure ongoing compliance and readiness for audits -- Keywords: cprogramm rlang information technology SAP GXP Lead/Architect [email protected] |
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| Wed Aug 14 22:49:00 UTC 2024 |