Digitization lead

As the Digitization Lead at Syngene International Limited, Bengaluru, you will play a crucial role in ensuring compliance activities related to ERP systems, thereby supporting quality assurance and data integrity in the operational systems. Your core purpose will be to act as a System Subject Matter Expert (SME) and oversee the validation of ERP systems in alignment with regulatory requirements and internal policies. Your responsibilities will include preparing, reviewing, and approving validation deliverables such as Impact Assessments, User Requirements Specifications (URS), Functional Requirements Specifications (FRS), and Validation Reports compliant with 21 CFR Part 11, EU Annex 11, and GAMP5. You will be involved in the implementation and maintenance of ERP systems like SAP, EDMS, and Track Wise, ensuring their validated state. Moreover, you will collaborate with IT, QA, and business stakeholders during system testing, deployments, and upgrades for ERP systems. As a part of your role, you will be required to assess and manage risks associated with ERP system changes, ensure adherence to company SOPs and regulatory guidelines, and act as a subject matter expert during internal and external audits. Additionally, you will mentor and guide junior team members on validation compliance best practices and lead investigations into deviations and issues arising from validation and audit activities. To excel in this role, you must have 13-18 years of experience in validation and compliance of GxP regulated ERP systems, along with a strong working knowledge of data integrity, good documentation practices, and regulatory requirements. Your educational background should include a Masters degree in Science, Pharmacy, Biotechnology, B. Tech, or IT-related field. At Syngene, we value excellence, integrity, and professionalism, and we expect all employees to consistently demonstrate alignment with these core values. As an Equal Opportunity Employer, we provide a dynamic environment where safety, innovation, and collaboration are at the forefront of everything we do.,