MANOJ KUMAR KOTTE

• Completed administrative and research duties per professor request.
• Performed statistical, qualitative, and quantitative analysis.
• Recorded data and maintained source documentation following good documentation practices.
• Gathered, organized and entered data into softwares.
• Provided comprehensive research assistance and support when designing and executing experiments.
• Contributed to professionally-written scientific paper for publication.
• Gathered, reviewed, and summarized literature from scientific journals such as SciFinder and PubMed and produced graphs and other scientific calculations using MS Excel.
• Planned, modified and executed research techniques, procedures and tests.
• Maintained and calibrated equipment for precision and accuracy.
• Used advanced statistical approaches and software tools to analyze data and test hypotheses.
• Drafted technical papers and other documentation for use by research leadership.
• Developed instruments to collect data, including experimental documentation and survey questions.
• Compiled and synthesized data to identify larger trends and research patterns impacting area of study.
• Conducted independent or supporting research on range of topics, following correct protocols for study integrity.
• Prepared research project documentation to facilitate approval processes.
• Met regularly with research team to identify issues and maintain study alignment with objectives.
• Input and modeled data to generate reports and charts for research stakeholders.
• Partnered with research team to strategize research and develop specific plans.
• Prepared summaries of research data for use in high-level meetings and presentations.
• Maintained database of research materials, documents and other paperwork.

• Computer System Validation Consultant with experience in a highly regulated environment (FDA Part 11, 58, 210, 211, 820, GLP, GCP, GMP, and GAMP 5) centered on compliance and delivery of high-quality risk assessment, design, implementation, validation, and maintenance solutions.

• Good exposure to various SDLC models including Agile (Scrum), and Water Fall models.

• Experience in planning and execution of Validation Master Plan (VMP), specifying requirements (URS/ FRS), Design Specifications (DS), creating protocols - Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), creating Requirements Traceability Matrix (RTM), and writing Validation Summary Report (VSR).

• Good experience in authoring, reviewing, and editing Standard Operating Procedures (SOP) and User Guidance Manuals, report writing, issue logs, routing documents for approvals, archiving the approved documents, and ensuring the global operational procedures are under compliance as per the current regulatory standards.

• Highly proficient with all the phases of the SDLC (System Development Life Cycle) process, and validation methodologies.

• Proficient in developing and executing Test Plans, Test Procedures, Test Scripts, and Test Cases and Performed Regression, Black box, User Acceptance Testing (UAT), and Performance Testing by using HP Quality Center and Load Runner. Expertise in preparing and reviewing Deviation Reports and Change Controls.

• Mentored students through office hours and one-on-one communication.
• Checked assignments, proctored tests and provided grades according to university standards.
• Documented attendance and completed assignments to maintain full class and student records.
• Coordinated homework and assignments for absent students.
• Worked with teachers in evaluating student progress, needs and gains.
• Conducted minimum number of on-site, in-the-field observations.
• Supervised research projects and student organizations, providing guidance to enhance learning outcomes.
• Offered guidance to students on academic and career planning to support professional goal setting.
• Engaged in scholarship research to contribute to academic community and stay informed about financial aid for students.
• Collaborated with other faculty and staff to improve teaching and learning by sharing resources and best practices.
• Collaborated with staff in curriculum reviews to improve course and program offerings.
• Developed and graded exams and assessments to evaluate student learning and provide feedback on performance.
• Kept accurate records of student performance to track student progress and provide feedback on performance.
• Assessed student learning to evaluate teaching method success and make necessary adjustments.
• Participated in and contributed to departmental meetings to stay informed about university policies and initiatives.