Rakesh Kumar Chiturupula

- Acting as a liaison between the Global departments of IT Operations, Quality Systems in Germany HQs and the local respective departments in the BI production site in Vienna, facilitating the collection and prioritization of business requirements and identifying local business needs in alignment with global IT standards

- Leading the deployment and rollout of projects related to systems and software in his/her assigned areas - at local/regional level - and handles relationships with external providers to ensure timely and efficient completion

- Keeping abreast of all new technological developments in order to identify IT technologies related to quality control and EHS processes that could provide Boehringer Ingelheim with a competitive advantage and proposes business process and/or system enhancements

- Driving IT innovation in the area of responsibility

- Act as IT Business Partner by providing functional and technical application management of implemented (parts of) quality IT systems in accordance with Service Level Agreements (SLA’s) and with a view to ensure continuity and stability for the user & organization.

- Supporting Trust Process (IT Risk assessments and Corporate Compliance).

- Validation Management (cGxP/GAMP5) of research equipment and computer systems in DBC and Develop and maintain data integrity assessments for all regulated equipments and computerized systems.

- Guarantee the continuity of the ICT infrastructure of the global DBC organization, in close alignment with corporate ICT and DFS with Project responsibility (value up between 250-500k)

- Global Quality Board member for Lab Automation and Digitization Project for DBC.

- To add value to the organization by supporting the development and deployment of Quality and Manufacturing Systems, Benchtop and analytical applications and also responsible for site Lab Automation activities.

- Quality/Manufacturing Systems and Lab Automation consulting (e.g. Empower CDS, LIMS, Trackwise, Documentum, CMMS, ELN, MES) - Computer System Validation Consultant (e,g, GAMP 5, IT Supplier Assessment).

- Lead team and consultants to ensure all the above information systems are compliant with the relevant authority's regulations and industry guidelines, including FDA CFR Title 21 and ICH cGMP guidelines.

- Key member of site Information Systems team to support successful FDA, EMA and HSA inspection and licensure for advance Single Use System Biotechnology manufacturing plant first in the industry

- Site IT Lead being responsible for handling and executing multiple projects according to organizational needs for GLP Facility (INVIVO Laboratories).

- Plan and manage the delivery of consulting and other services by external and internal suppliers in order to ensure delivered service levels meet the business needs.

- Accountable for budget upto USD 2 million, Control USD 250K. Document IS expenditures, including capital expenditures, in line with local and PMI requirements, perform service cost management and chargeback activities and regularly carry out budget controls and cost projections during the year.

- People management of team size of 5 resources supporting LIMS/SCADA/SEND/DIGITAL PATHOLOGY/BENCHTOP Systems.

- Ensure IS services or projects required by customers are planned, delivered, controlled and continuously improved within the agreed service levels by leveraging standard service management practices.

- As system manager responsible for managing the system to provide ITIL related support, including Application, change and release management and Laboratory Application support, sample lifecycle dynamics and analysis.

- Responsible for strategic decision and projects for LIMS, EM and LimsLink Application.

- Manage the incident and problem management process; communicate with customers, service providers and Coordinate day-to-day execution of incident and problem management resolution as defined by business processes.

- Coordinate and take ownership of the Change and Release Manager role

– facilitate changes, conduct Change Advisory Boards and carry out Release Management (Project Manager) in close collaboration with the service provider and the LoB, facilitate application support on a day-to-day basis.

- Managed an application support team to meet agreed standards, availability and SLA’s while maintaining a cohesive and motivate team.

- Experience as ITQA and has detailed experience of CSV process and implementation. Has detailed test and compliance experience in the CSV area.

- Budget Management/Cost analysis.

ILIMS (StarLIMS) is a ISP LIMS Product which Provide cost effective laboratory information management system solution that meets the needs of the ISP Quality organization and its customers. I would ensure that software changes are thoroughly tested and validated prior to being moved into the UAT stage of the SDLC. As a LIMS Systems Analyst, was responsible for,

- ILIMS support in Europe and Coordinate and work with support team to solve application issues. - Design and Develop/Modify Validation Protocol and Validation Master Plan.

- Validate the system by Preparation and Execution of OQ/PQ Test Scripts of ILIMS for different Business Module (BM) Release.

- ILIMS Rollout in Europe and Improve Software Delivery. Responsible for Software Quality Assurance and Enterprise Monitoring Tool.

Worked through IT Consultancy as Lab IT System consultant and my roles include the Training and building the team for Lab Automation CoE. I have worked for clients such as Pfizer R&D, Manufacturing and Legacy Wyeth Manufacturing across global in SQL*LIMS, Labware LIMS and Empower Application. I have also involved in Supporting MODA, Developing Minitab Queries and Developing COA reports using Altova Style Vision.