Key Responsibilities :
- 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
Technical / Functional 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 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.) desiredExperience 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.Experience :
10-12 Years of IT experienceBehavioral Skills :
Strong commitment to exceptional customer experience, and a high level of dedicationenthusiasm, motivation, and persuasive ability in a team and cross-functional environment.Excellent speaking-listening-writing skills, attention to details, proactive self-starterAbility to work successfully in a dynamic, ambiguous environment.Ability to meet tight deadlines and prioritize workloads.Skills Required
Project Coordination, Quality Assurance