Senior Manager - CDMO IT

ORGANISATIONAL OVERVIEW We, Lambda Therapeutic Research Limited are a leading global Clinical Research Organization (CRO) headquartered in Ahmedabad – India, with facilities and operations in Mehsana (India), Warsaw (Poland), London (UK), Pittsburgh (USA), Las Vegas (USA) and Fargo (USA). Over 1500 employees are working across the globe in these facilities. Lambda offers Full-spectrum clinical trial solutions empowered by more than 20 years of service to the biopharmaceutical and generic industry. At Lambda, our gamut of services under the clinical research domain are executed with comprehensive efforts, to deliver positive results. Led by a management team of highly qualified & experienced industry leaders, we apply innovative technologies, therapeutic expertise, and a commitment to quality to help clients develop products safely, effectively, and quickly. Delivering the best accomplished by hiring the best. Employees are the pillars that hold up every quality promise that we make. That is why, we at Lambda are always looking for qualified and energetic individuals, with a desire for excellence, to join our team JOB DETAILS Lead the planning, implementation of IT infrastructure and network for the process and analytical functions of CDMO. To oversee and support during installation and implementation of IT systems, manufacturing equipment, Enterprise applications like SAP ERP, Document Management Systems, Testing and Training Systems and Quality and Manufacturing systems like SCADA, PLCs, MES (eBMR, L2 Integration), LIMS and other highly complex automated systems Support the technical team to ensure that process data is available via OPC/similar interfaces to centralised data base systems (e.,g Aveva PI). Develop, Implement and ensure Consistent & Documented compliance to required CSV frameworks, policies, and procedures in alignment with pharmaceutical industry regulations (GxP, GAMP5, Safety Health & Environmental (SHE), Data Integrity (DI), Quality and Best Practice requirements etc.). Act as a system administrator for IT system and be primary SPOC for user management access functions. Act as a custodian of electronic data and responsible for data backup and restoration. Assist vendor for trouble shooting related to IT systems.  Understand the QMS requirements and Collaborate with cross-functional teams within Company to ensure quality standards for software development, infrastructure management, and data integrity. To provide regular, accurate and timely reporting of progress to the Site leadership, CQA, IT-QA, Project sponsors and Stakeholders. Ensure that Computer systems, processes, and documentation adhere to regulatory requirements and internal quality standards, and be primary presenter during audits. Collaborate with Supplier, QA & ITQA teams to address audit findings and implement corrective and preventive actions (CAPAs). Assess, Evaluate, Monitor and carry out periodic reviews of Computer…