elNB, LIMS, CDS - Implementation Deputy Manager with following skills and experience.
• Responsible for research informatics operation and support for informatics applications
• Understand the critical business processes needs in various departments / operations of the organization and suggest solutions / ensure development and implementation.
• Implement new projects / solutions as per business needs. Coordinates between scientists and vendor for any solution development / implementation
• Coordinate with clients to roll out scientific applications
• Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety
• Attend training on environment, health, and safety (EHS) measures imparted company
Educational Qualification: Postgraduate in Science/MCA
• 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 in working with Data acquisition layer /Comprehensive Data Management /Data Lake/ Data Mart (Data Warehouse) and Scientific Data Management System (SDMS).
• Familiarity with basic scientific concepts (calibration, basic statistics, etc.) desired
• Experience with Software development life cycle (SDLC) and Computer System Validations (CSV). Should have experience of 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.
• Must have excellent command over industry business processes across business functions, and experience of working in the Indian CRO/Pharmaceutical market.
• 10-12 Years of IT experience
• Strong commitment to exceptional customer experience, and a high level of dedication
enthusiasm, motivation, and persuasive ability in a team and cross-functional environment.
• Excellent speaking-listening-writing skills, attention to details, proactive self-starter
• Ability to work successfully in a dynamic, ambiguous environment.
• Ability to meet tight deadlines and prioritize workloads.