Sweta Sharma

Responsibilities• Proven experience in computer systems validation, with knowledge and understanding of 21 CFR Part 11, Annex 11, GAMP 5, FDA and EMA regulations in Agile, Waterfall and Hybrid model• Provide computer system validation consultation and training to IT team to ensure compliance• Responsible for leading and managing implementation and validation of R&D, Product Supply applications.

Liaison between business users and development teams by serving as business problem solvers. Co-ordinate with Developers, Clients, Testers and other individuals involved in the project to resolve the identified issues on the basis of severity or priority. Comprehensive knowledge of Software Development Life Cycle models like Agile& Waterfall, having thorough understanding of various phases like Requirement gathering, Analysis/Design, Development, Testing and Release.

•Provide expert suggestion, quality check, and providing solutions for different standard concepts.•Giving the solutions to clients for TMH (Tata-McGraw Hill), McMillan, Wiley, and Pearson publication books related with engineering. Ensuring quality and error free scripts. Meeting deadlines on short notice.•Technical research and Technical writing •Preparing WBT’s and ILT’s.•Working on tools like captivate, articulate, madcap flare and LMS software. Quality check by ensuring the quality of technical content

•Maintaining technical data and modifying it according to the updations. •Preparing tender documents and client oriented specifications and data. •Following specific writing standards and ensuring delivery on the due date. •Research about the specifications and requirements of the client regarding network connection. •Preparation of monthly reports of types of antennas installed at various locations.