Sunil Racha Email & Phone Number

Morristown, New Jersey, United States

- Oversaw OrderPoint, Compliance Intelligence, and Ti Home Office Admin roadmaps.- Partnered with 15 clients, net worth over $200 Billion, ensuring timely feature delivery.- Authored user stories and engineering backlog for Agile development.- Enhanced product strategies through Production Support insights, gaining 4 new clients.- Leveraged user data to boost customer satisfaction by 150%.- Addressed potential product and satisfaction issues proactively.- Presented demos, and assisted marketing & sales in client pitches.- Performed market analysis, and outlined market segments, and customer profiles.- Developed varied pricing models, meeting client compliance needs and revenue goals.- Set KPIs for support efficiency and improvements.- Collaborated with UX engineers, enhancing customer engagement by 25%.- Managed over 30 integrations, including Salesforce and Veeva.- Ensured FDA compliance and reporting.- Contributed to product vision, focusing on user-based segmentation.- Guided QA in A/B testing, case development, knowledge transfer, and validation.- Compiled 2500+ JIRA tickets detailing business requirements and testing scenarios.

Morristown, New Jersey

• Strong understanding of 21 CFR part 11 and FDA regulations and GxP (GDP, GCP, cGMP) requirements including electronic records, electronic signatures, and Documentation. • Understood the client’s business requirements and acted as liaison between the technical team & and non-technical team for several project implementations.• Established the production support team and devised strategies to achieve 100% customer satisfaction.• Steered implementation of various data integrations (ETLs and APIs) for quick production launches and short• Participated in sales pitches and performed client demos.• Period review of the performance of the applications through data analysis (using SQL, Python) and initiated Change Controls to maintain the quality and compliance of the software product.

Morristown, New Jersey, United States

• Authored comprehensive documentation for the validation lifecycle, including user acceptance tests, user requirements, functional specifications, design specifications, validation plans, risk assessments, requirements traceability matrices, and validation final reports for the Order Point application, introducing a new prescription drug sampling program solution.• Designed and developed the Validation Master Plan and system Test Plan for various in-house applications, establishing a structured framework for validation processes.• Played a pivotal role in documenting user requirements, and supporting the development team in creating a solid foundation for system development.• Validated Change Requests for system upgrades related to existing sampling program solutions, ensuring the seamless integration of improvements in applications such as Direct to Practitioner, Compliance Intelligence, and Sample Accountability.• Developed and maintained Requirement Traceability Matrix, enhancing transparency and traceability throughout the validation process.

* Catalyzed sugar reactions and studied kinetics. Led pilot plant for rare sugar production.* Developed SOPs for equipment and documented lab reactor safety protocols.* Performed and participated in biodiesel production scale-up.* Reviewed process diagrams and wrote LIMS validation plans/protocols.* Operated lab equipment (HPLC, GC, autoclaves, incubators, bioreactors).

Vadodara Area, India

• Oversaw daily operations of the Tunnel Kiln in the Porcelain insulators manufacturing unit, ensuring seamless production.• Conducted comprehensive research on diverse ceramic coatings, evaluating their impact on workers' health and well-being.• Undertook a thorough examination of energy consumption patterns within the Kiln division, compiling detailed reports. Analyzed the data and recommended strategic changes to enhance energy efficiency.• Investigated various safety issues in plant operations, proposing and implementing essential changes to enhance safety measures and protocols.

Hyderabad Area, India

• Led an in-depth exploration of cutting-edge Anaerobic treatment methods for handling organic municipal solid waste in third-world contexts.• Our dynamic chemical engineering team translated these insights into a robust proposal to the State Government, addressing the intricate waste treatment challenges of Hyderabad's Jawaharnagar dump yard—one of India's largest disposal sites.• Our impactful work, featuring groundbreaking findings and forward-thinking recommendations, was spotlighted in the published paper 'Treatment and Disposal of Municipal Solid Waste in Third World Countries: A Critical Review' in the International Journal of NeBIO (Volume III, Issue 5, December 2012). This underscored our expertise in data-driven analysis, strategic planning, and innovative problem-solving in environmental engineering.

Bokaro Area, India

• As a valuable team member, I played a pivotal role in optimizing the performance of Reheating furnaces at the SAIL - Bokaro steel plant's metal molding unit.• My responsibilities included a detailed examination of input energy elements in the steel reheating process at the "Hot strip mill," with a keen focus on maintaining and enhancing the steel's crucial elastic properties.• Leveraging my skills in data analysis and process optimization, I successfully scrutinized energy consumption patterns and operational data of the furnaces. Subsequently, I applied my expertise to develop and implement strategies that significantly improved efficiency.

Executive Mba, Data-Driven Product Management

Master'S Degree, Chemical Engineering, 3.8

Activities and Societies: - International Cultural Ambassador Master of Engineering (M.Engg) Chemical Engineering

Bachelor'S Degree, Chemical Engineering Technology, 6.7

Activities and Societies: 4 Projects