Senior Manager - Quality IT Compliance

Job Title

Senior Manager – CQ-IT

Business Unit

Global Quality & Compliance

Job Grade

Senior Manager

Location :

Mumbai

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

Key Responsibilities

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.Perform periodic reviews of critical SAP controls, electronic records, electronic signatures and audit trail functionality.Conduct Data Integrity Risk Assessments (DIRA) for SAP applications and associated interfaces.

SAP Security & Access Governance

Segregation of Duties (SoD) reviews and mitigation activities for SAP business critical transactions.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.Assess impact of interface changes and ensure appropriate validation and data integrity controls are implemented.

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.Maintain inspection readiness for SAP validation lifecycle documentation.

Metrics & Continuous Improvement

Develop and monitor SAP compliance KPIs, validation metrics and periodic review effectiveness measures.Identify opportunities for process improvement, automation and compliance enhancement across SAP-managed processes.

Travel Estimate

Frequent travel required, Approx. 70%

Job Requirements

Educational Qualification

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

SAP ECC/S4HANA Experience

SAP Material Management process knowledge and validation/testing of controlled business transactions

SAP Certified Development Associate

Experience

Tenure : 12 to 18 Yrs

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).