IT Validation / GxP Systems Specialist

IT Validation / GxP Systems Specialist

Roles & Responsibilities Review and approve change controls, investigation reports, deviations, and CAPAs. Evaluate and authorize qualification and validation documents related to GxP systems. Review and approve IT system change requests, problem reports, and associated deliverables. Ensure compliance and maintain controls for GxP-regulated software systems. Provide support to plant teams during regulatory and customer audits. Ensure implementation of projects through approved SOPs and GAMP guidelines. Lead the rollout of projects and system enhancements across all business units. Review standard operating procedures (SOPs) pertaining to IT systems. Monitor implemented projects and deliver user awareness sessions as needed. Coordinate with other business units to harmonize business processes and uphold safety, health, and environmental standards. Ensure adherence to cGMP requirements in all operational activities. Execute any other additional tasks as assigned by supervisory staff.

Qualifications

• Educational Qualification: Graduation in IT- Engineering, Computer Science or a related field is mandatory. Minimum Work

Experience

• 3+ / 7+ years of experience. Skills & Attributes & Critical Exposures Functional

Skills

• Review and approve change controls, investigation reports, deviations, and CAPAs. Evaluate and authorize qualification and validation documents related to GxP systems. Review and approve IT system change requests, problem reports, and associated deliverables. Ensure compliance and maintain controls for GxP-regulated software systems. Provide support to plant teams during regulatory and customer audits. Ensure implementation of projects through approved SOPs and GAMP guidelines. Lead the rollout of projects and system enhancements across all business units. Review standard operating procedures (SOPs) pertaining to IT systems. Monitor implemented projects and deliver user awareness sessions as needed. Coordinate with other business units to harmonize business processes and uphold safety, health, and environmental standards. Ensure adherence to cGMP requirements in all operational activities. Execute any other additional tasks as assigned by supervisory staff. Behavioral

Skills

• Execution Focus: You consistently drive results by aligning teams around delivery goals and maintaining momentum through change and complexity. Cross-Functional Collaboration: You cultivate strong partnerships across teams and stakeholders, enabling seamless coordination and alignment throughout the product lifecycle. Critical Exposures: 3+ years experience as IT for a global company is desired. Technical Exposures: Ensure compliance and maintain controls for GxP-regulated software systems & support to plant teams during regulatory and customer audits.

• Additional Information

• Benefits Offered

• At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.