Designation : Senior Manager

Function : Global Quality & Compliance

Functional Area : CQ-IT

Job Role Summary : Global SAP Compliance, Data Integrity & Regulatory Compliance of SAP Systems

Job Profile

• SAP Platform & Module Expertise: Act as Global SAP Compliance SME for SAP ECC/S4 HANA environments across manufacturing, quality, warehouse and laboratory operations.
• Review and assess SAP module configurations impacting GxP processes including MM, QM, PP, WM/EWM, SD, PM and Batch Management.
• Support implementation, enhancement and validation of SAP integrated business processes across manufacturing and quality functions.
• Review and approve SAP functional specifications, configuration documents, design documents and validation deliverables.
• Data Integrity & Regulatory Compliance: Ensure SAP systems comply with ALCOA+ principles and Data Integrity expectations as defined by FDA, MHRA, WHO and EU GMP guidelines.
• Conduct Data Integrity Risk Assessments (DIRA) for SAP applications and associated interfaces.
• SAP Security & Access Governance:



Review and approve SAP roles, authorization matrices and privileged access controls. Ensure periodic user access review, emergency access management and privileged account monitoring are performed as per company procedures.
• SAP Interfaces & Integration Validation: Provide CSV and compliance oversight for SAP interfaces integrated with LIMS, MES, TrackWise, WMS, Laboratory Systems and other GxP applications.
• Inspection & Audit Readiness: Serve as SME during regulatory inspections and customer audits involving SAP systems and computerized system validation.
• Support preparation of audit responses, CAPA plans and remediation activities related to SAP compliance observations.

Job Requirements

• 12-18 Years of Pharma Industry Experience in regulated workplace
• SAP ECC/S4HANA experience
• SAP Material Management process knowledge and validation/testing of controlled business transactions
• SAP Certified Development

📌 Senior Manager – CQ-IT (Mumbai)
🏢 Qvents.In
📍 Mumbai