Informatics Manager

Job Description

Job Title: Informatics Qualification Postgraduate in Science/MCA with a minimum of 10- 18 years of IT experience in the Pharmaceutical / Life science domain Technical Skills Experience in demonstrating a track record of delivering scientific solutions in the pharmaceutical and CRO industry. Experience in the implementation of Informatic applications like (Electronic Laboratory Notebooks(elNB), Laboratory Information Management System, Chromatography Data system (CDS) and other scientific applications. Experience with Software development life cycle (SDLC) and Computer System Validation (CSV). Should have experience in running projects with CSV life cycle. Candidate should have knowledge of current regulatory & Guidelines (GAMP5) for CSV, i.e. 21 CFR Part 11 ERES, Part 820, Part 210 & 211, EU Annex 11, ICHQ9 and SOP requirements of computerized systems w.r.t. data security, traceability and integrity. Candidate should be familiar with GCP, GLP and GMP guidelines/SOPs. The candidate should have skills in managing Regulatory & Client Audits (experience in supporting internal and external audits). Other Skills: Strong leadership, communication, consulting and influencing skills. Must have experience in resource management - channelizing resources to track current and future program resource assignments. Must have excellent team collaboration skills and the ability to lead and motivate cross-functional teams. Strong analytical and communication skills are required. Roles and Responsibilities: Responsible for supporting informatics applications of the assigned departments. In collaboration with the scientific community identify, evaluate and implement software applications meeting business requirements. Implement new projects/solutions as per business needs. Coordinates between scientists and vendors for any solution development/implementation Ensure effective utilization of scientific systems and applications Coordinate with Syngene clients and/or vendors to roll out scientific applications extended to Syngene Facilitate computer system validation and ensures that scientific applications are GxP compliant as per the operating unit requirements Responsible for ensuring 21 CFR Part 11 compliance for enterprise & standalone applications Focus on near-zero downtime for enterprise applications Technical support and administration of scientific and associated applications. Challenges / error handling, escalation and troubleshooting of scientific and associated applications. Responsible for effective coordination among clients, operating unit and internal IT team for the application / infrastructure challenges faced by the operating unit to minimize or eradicate the downtime Responsible to provide the right solution for the challenges faced by the operating units Responsible for implementation / suggestion of any IT related process improvements for the operating units Location: Bangalore