Elnb , Lims , Cds - Implementation Deputy Manager @ Augusta Infotech

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.) 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.

Experience:

10-12 Years of IT experience

Behavioral Skills:

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.