Senior Manager – CQ-IT

Qvents.In; Maharashtra; On-site; INR 4,000,000 - 7,000,000; Full time

Job summary

Sun Pharmaceutical Industries Ltd. is seeking a Senior Manager for Global SAP Compliance, Data Integrity and Regulatory Compliance of SAP Systems in Mumbai, Maharashtra. You will oversee SAP ECC/S4HANA across manufacturing, QA, and labs, ensuring GxP alignment and data integrity.

You will review configurations, manage security and interfaces with LIMS/MES/TrackWise/WMS, and support inspections and audits with CAPA remediation as needed.

Qualifications

• 12–18 years of pharma industry experience in regulated environments.
• SAP ECC/S4HANA expertise with MM module knowledge.
• Proven SAP validation/testing experience.
• SAP Certified Development Associate.

Responsibilities

• Act as Global SAP Compliance SME for ECC/S4HANA across manufacturing, QA, warehouse and labs.
• Review SAP configurations impacting GxP processes (MM, QM, PP, WM/EWM, SD, PM, Batch Management).
• Validate and support integrated business processes across manufacturing and quality functions.
• Oversee data integrity in line with ALCOA+ and regulatory guidelines.
• Manage SAP security, roles, access reviews and emergency access controls.
• Provide CSV oversight for interfaces with LIMS, MES, TrackWise, WMS.
• Assist regulatory inspections and customer audits of SAP systems.
• Support audit responses, CAPA and remediation actions for SAP compliance.

Skills

SAP compliance

Data Integrity

Regulatory Compliance

Education

Bachelor's degree in Engineering (B.E.) – Information Science / IT

Tools

LIMS

MES

TrackWise

WMS

Job description

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 environment
• SAP ECC/S4HANA experience
• SAP Material Management process knowledge and validation/testing of controlled business transactions
• SAP Certified Development Associate

Work / Job Experience

12-18 Years

Type of Experience

SAP System compliance, CSV, SAP Material Management

Academic Qualifications

Bachelor of Engineering (B.E.) – Information Science / IT,

Job Post Link

https://tinyurl.com/3kdnscec

Employment Type / Location

• Full Time
• India | Maharashtra | Mumbai
• Posted 1 week ago

Website Linkedin

Sun Pharmaceutical Industries Ltd