Hi. I'm Sunil Racha
Technical Product Owner
Hi. I'm Sunil Racha
Technical Product Owner
About me
Over 8 years of experience in the Health Care/Life sciences industry in various roles from hands-on process engineering and research to diving deep into IT with roles in Computer System Validation and Business Analysis. During the journey, I honed my technical acumen by gathering knowledge on process design, Quality assurance, Communication, Data analysis, Software Development Life Cycle (SDLC), Equipment and Software Validation, Project Management, Marketing Strategies, and Product Management.
From a scientific background, I've grown into an IT Technical Product Owner role, driving the vision of Drug Sampling Compliance in FDA regulated space. My strength lies in adaptability, quick learning, and a genuine passion for taking on challenges. I bring youthful energy coupled with seasoned experience, always committed to contributing to organizational growth and sustainability. Seeking an opportunity to lead and motivate a team within a mission-driven organization, utilizing strong analytical and problem-solving skills to address complex business challenges and make a positive impact.
Work Experience
Technical Product Owner
Company: QPharma Inc.
Location: Morristown, NJ
Period: June 2020 – Current
- Managed the roadmap of rep applications – OrderPoint (Online ordering system), Compliance Intelligence (Report generation system), Ti HomeOffice Admin (Admin console for rep activity management).
- Worked closely with 15 clients whose combined net worth is more than $200 Billion and their engineering teams to deliver functionalities on time.
- Defined Product requirements in the form of user stories and an engineering backlog – Both the Waterfall and Agile models were followed.
- Explored the Production Support channel to Identify the customer pain points and improved the product roadmaps that brought in 4 additional clients.
- Explored the user engagement data to increase customer service satisfaction by 150%.
- Proactively identified and resolved issues that may impact product quality & customer satisfaction.
- Gave product demos and worked alongside the marketing & sales team on client pitches.
- Piloted software development around multi-billion-dollar client requirements while still satisfying FDA, 21CFRPart11, and PDMA regulations.
- Employed necessary measures to maintain HIPAA compliance requirements and facilitated necessary reporting capabilities.
- Steered implementation of over 30 Integrations (ETLs and APIs Combined) – with Salesforce, Veeva, and other client in-house systems.
- Conducted market research and competitive analysis to derive market segmentation and customer persona.
- Worked on multiple pricing strategies for different clients adhering to the company’s expected revenue growth while satisfying the client’s budget requirements and Compliance Standards
- Established Key Performance Indexes (KPI) to measure the efficiency of support operations and drive reliability score of the applications.
- Worked directly with the QA testing team in A/B testing, derived testing cases, conducted KT sessions, and facilitated the validation activities.
- Contributing towards overall product vision by working on increasing the product portfolio through user-base segmentation.
- Amassed Requirement gathering experience by writing more than 2500 Technical JIRA tickets for Software development with clear focus on business user stories, functional requirements, executive summary & test scenarios.
- Automated many tedious and time-consuming tasks via JIRA automation to increase efficiency in ticket writing, approvals, proposal reviews, SLA reporting, and KPI dashboards.
- Worked in both Waterfall and Agile development methodologies, including both Scrum and Kanban styles.
- Has experience in implementing and integrating ERP systems in sampling warehouse systems.
Business Analyst/Support Engineer
Company: Validation Associates LLC. – Client: QPharma Inc.
Location: Morristown, NJ
Period: June 2017 – June 2020
- 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 & non-technical team for several project implementations.
- Acted as Subject Matter Expert (SME) for 9 applications that contribute to 70% of QPharma’s revenue.
- Established the production support team and devised strategies to achieve 100% customer satisfaction.
- Steered implementation of over 15 data integrations (ETLs and APIs) for quick production launches and short
- Participated in sales pitches and performed client demos.
- Performed periodic review of application performance through data analysis (using SQL, Python) and initiated Change Controls to maintain the quality & compliance of the software product.
Validation Engineer
Company: Validation Associates LLC. – Client: QPharma Inc.
Location: Morristown, NJ
Period: Oct 2016 – June 2017
- Authored all documentation related to the validation lifecycle including user acceptance tests, user requirements, functional specifications, design specifications, validation plans (VP), risk assessments (RA), requirements traceability matrices (RTM), Installation Qualification (IQ), Operational Qualification (OQ), & Performance Qualification (PQ) protocols and Validation Final Report (VFR) for Order Point application (a new prescription drug sampling program solution)
- Designed and Developed the Validation Master Plan and system Test Plan for several in-house applications.
- Assisted the development team in documenting the User Requirements.
- Validated Change Requests (CR) for system upgrades related to existing sampling program solutions including Direct to Practitioner (DTP), Compliance Intelligence, and Sample Accountability (SA) applications.
- Developed and maintained Requirement Traceability Matrix (RTM).
- Performed Unit Testing, Ad-Hoc Testing, User Acceptance Testing, and Regression Testing.
- Validated Sample Disbursement process of Sales Representative logging into the Salesforce application for disbursing a sample to an Eligible Practitioner.
- Perform dry runs before validation execution to eliminate script errors and minimize deviations.
- Performed project planning, coordinating team, tracking activities, deadline assessment activities
Perform Risk Assessment of the requirements, to determine the extent of validation testing to be performed on the requirements. - Analyzed process data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
- Helped in compliance audits of systems, general assessments, risk assessments, GAP analysis, and 21CFR-Part11 assessments.
- Wrote SOPs for several in-house functions/procedures.
- Initiated change requests and provided in-depth risk assessments of the systems and processes.
Process Quality Engineer
Company: Nagarjuna Fertilizers & Chemicals
Location: Hyderabad, India
Period: Oct 2013 – May 2014
- Conducted Heterogeneous Enzymatic Catalysis Reactions on sugars.
- Studied reaction kinetics and conducted pilot plant operations for mass production of rare sugars.
- Helped in drafting Standard Operating Procedures (SOPs) for Process equipment.
- Documented safety measures for Lab scale reactors and fermenters.
- Performed and involved in various scale-up operations of the Biodiesel production process.
- Reviewed PFDs and P&IDs
- Wrote Validation Plan and validation protocols to validate in-house LIMS application.
- Worked on Laboratory equipment like Chromatography (HPLC & GC), Autoclaves, Incubators, and Bioreactors.
Engineering Intern
Company: Aditya Birla Insulators
Location: Gujarat, India
Period: Jan 2013 – June 2013
- Maintained everyday operations of Tunnel kiln in Porcelain insulators manufacturing unit.
- Due diligence on the effects of various ceramic coatings on workers’ health and documentation.
- Studied and compiled reports on Energy usage in their Kiln division analyzed the data and proposed changes to save energy.
- Led a study team on safety issues in plant operations and proposed changes in safety measurements.
Engineering Intern
Company: Bokaro Steel Plant – SAIL INDIA
Location: Jharkhand, India
Period: May 2011 – July 2011
- Fieldwork in a team with Reheating furnaces - plant's metal molding unit.
- Rigorously analyzed Input Energy elements consumed in the process of reheating steel at a “Hot strip mill” to maintain its elastic properties.
- Successfully compiled Energy consumption details & working potentials and developed strategies to improve its efficiency.
Education
Bachelor's Chemical Engineering
Executive MBA Cert. Data-Driven Product Mgmt
Master's Chemical Engineering
I have a Bachelor's degree in Chemical Engineering from one of the India's finest universities - BITS Pilani.
2009-2013
Master's Chemical Engineering
Executive MBA Cert. Data-Driven Product Mgmt
Master's Chemical Engineering
I completed my Master's in Chemical Engineering from Lamar University, Texas.
2014-2016
Executive MBA Cert. Data-Driven Product Mgmt
Executive MBA Cert. Data-Driven Product Mgmt
Executive MBA Cert. Data-Driven Product Mgmt
I gained first professional Product management education in form of an Executive MBA certificate in Data-driven Product Management from IIM-Lucknow, India.
2021-2022
Research Experience/Projects
OFMSW
Biodiesel Production from Pure Veg. Oil
Biodiesel Production from Pure Veg. Oil
Institute: BITS Pilani Hyderabad
Location: Hyderabad, India
Period: June 2012 – Aug 2012
Extensively reviewed various available anaerobic treatment methods of organic fraction of municipal solid wastes (OFMSW) in third world countries and proposed an effective and practical solution to the State Govt. to treat waste in the Jawahar Nagar dump yard in Hyderabad. This is one of the largest municipal solid waste disposal sites in India. This work resulted in a successful co-authored journal on the Journal NeBIO: Volume III Issue 5: Dec 2012.
Biodiesel Production from Pure Veg. Oil
Biodiesel Production from Pure Veg. Oil
Biodiesel Production from Pure Veg. Oil
Institute: BITS Pilani Hyderabad
Location: Hyderabad, India
Period: Jan 2012 – May 2012
Using Vegetable oil as a source, several designed experiments were conducted to find key parameters and their depth of interaction through Factorial Analysis (DoE). Worked extensively through Gas Chromatography to increase the percentage of yield by 15%.
Lactic Acid Production from Rice husk
Lactic Acid Production from Rice husk
Lactic Acid Production from Rice husk
Institute: BITS Pilani Hyderabad
Location: Hyderabad, India
Period: Jan 2012 – May 2012
Investigated several alternative syntheses to produce lactic acid in a faster way. Worked towards optimization of the current standard procedure to get the maximum yield out of unusable rice husk and successfully showed a satisfactory yield of 95%.
Review of UASB Reactor Technologies
Lactic Acid Production from Rice husk
Lactic Acid Production from Rice husk
Institute: BITS Pilani Hyderabad
Location: Hyderabad, India
Period: Aug 2012 – Dec 2012
Consolidated the knowledge available on the technological developments made in the UASB reactor, both in designing and operational viewpoints since its inception through a study-oriented approach.
Technical Skills and Core-Competencies
Problem Solver - Self motivated - Detail Oriented - Tech Savvy - Strong ability to connect the dots
Problem Solver - Self motivated - Detail Oriented - Tech Savvy - Strong ability to connect the dots
Problem Solver - Self motivated - Detail Oriented - Tech Savvy - Strong ability to connect the dots
Problem Solver - Self motivated - Detail Oriented - Tech Savvy - Strong ability to connect the dots
Problem Solver - Self motivated - Detail Oriented - Tech Savvy - Strong ability to connect the dots
Problem Solver - Self motivated - Detail Oriented - Tech Savvy - Strong ability to connect the dots
Oracle SQL - AWS S3 - Redshift - JIRA/Atlassian - Visual Studio - Salesforce - Workbench - Power BI
Oracle SQL - AWS S3 - Redshift - JIRA/Atlassian - Visual Studio - Salesforce - Workbench - Power BI
Oracle SQL - AWS S3 - Redshift - JIRA/Atlassian - Visual Studio - Salesforce - Workbench - Power BI
Oracle SQL - AWS S3 - Redshift - JIRA/Atlassian - Visual Studio - Salesforce - Workbench - Power BI
Oracle SQL - AWS S3 - Redshift - JIRA/Atlassian - Visual Studio - Salesforce - Workbench - Power BI
Oracle SQL - AWS S3 - Redshift - JIRA/Atlassian - Visual Studio - Salesforce - Workbench - Power BI
Data Analysis - Product Roadmap - Fast Learner - Strong Customer Service - Visualization Skills
Data Analysis - Product Roadmap - Fast Learner - Strong Customer Service - Visualization Skills
Data Analysis - Product Roadmap - Fast Learner - Strong Customer Service - Visualization Skills
Data Analysis - Product Roadmap - Fast Learner - Strong Customer Service - Visualization Skills
Data Analysis - Product Roadmap - Fast Learner - Strong Customer Service - Visualization Skills
Data Analysis - Product Roadmap - Fast Learner - Strong Customer Service - Visualization Skills
LIMS - FDA - 21CFR11 - Agile & Waterfall - Scrum - Postman - SysML - Python - C - ExxagoReports- ETL
LIMS - FDA - 21CFR11 - Agile & Waterfall - Scrum - Postman - SysML - Python - C - ExxagoReports- ETL
LIMS - FDA - 21CFR11 - Agile & Waterfall - Scrum - Postman - SysML - Python - C - ExxagoReports- ETL
LIMS - FDA - 21CFR11 - Agile & Waterfall - Scrum - Postman - SysML - Python - C - ExxagoReports- ETL
LIMS - FDA - 21CFR11 - Agile & Waterfall - Scrum - Postman - SysML - Python - C - ExxagoReports- ETL
LIMS - FDA - 21CFR11 - Agile & Waterfall - Scrum - Postman - SysML - Python - C - ExxagoReports- ETL
API - Team Player - Must Disciplinary - MS Office - Veeva CRM - ChatGPT - SSIS - ERP Systems
API - Team Player - Must Disciplinary - MS Office - Veeva CRM - ChatGPT - SSIS - ERP Systems
API - Team Player - Must Disciplinary - MS Office - Veeva CRM - ChatGPT - SSIS - ERP Systems
API - Team Player - Must Disciplinary - MS Office - Veeva CRM - ChatGPT - SSIS - ERP Systems
API - Team Player - Must Disciplinary - MS Office - Veeva CRM - ChatGPT - SSIS - ERP Systems
API - Team Player - Must Disciplinary - MS Office - Veeva CRM - ChatGPT - SSIS - ERP Systems
Interests & Hobbies
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