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On-site position: Need SAP GXP Lead or Architect at Remote, Remote, USA
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Raj,

VSII

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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
On-site position: Need SAP GXP Lead or Architect
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Tue Aug 20 21:45:00 UTC 2024

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