SOURI MADDIPATTI
Cary,NC
Summary
Over 25 years of experience leading IT projects, implementing IT systems, and validating computer systems. Strong skill set in requirements analysis, scope management, design, build, and testing. Excel in performing GxP gap analysis and extensive knowledge of GxP processes and computer system validation in the life science industry. Ability to build relationships with cross-functional teams, creating a collaborative environment and influencing critical decision-making. Expertise in techno-functional project management involving QMS, LMS, CMMS, EDMS, and PLM systems. Comprehensive understanding of regulatory standards such as 21 CFR Part 11, Annex 11, GAMP 5, data integrity, FDA QSR regulation, and ISO 9001. Conducted system process audits, investigations, and assessed the effectiveness of CAPAs throughout career. Successfully validated various systems in on-premises, SaaS, and PaaS environments while maintaining a strong understanding of GDPR regulations. Consistently grown in responsibilities from analyst to team lead to department manager.
Overview
23
23
years of professional experience
1
1
Certification
Work History
IT Consultant – GxP Systems
Sage Therapeutics
06.2023 - Current
- As IT Consultant, I was responsible to ensure I maintain the validated state of the systems
- Conducted a detailed analysis of current system to determine current documentation and process documents
- In cases where there were gaps, worked with QA and CVS leads to improve the documentation
- Conducted detailed Release Impact Analysis for GxP system to ensure the releases are controlled
- Conducted DI and Audit Trails reviews for GxP systems
- As we were moving to a more risk-based validation, assessed the validation approach and risk
- Based on that a determination is made to the best validation approach
- The validation plan then looks at the set of documentation that will be needed as per the risk assessed
- Authored the required documents for the Computer Systems Validation (CSV) and moved them to approval
- As the IT Consultant, it was my responsibility to maintain the business systems to ensure their high productivity
- When systems need updates, I was required to manage the Change Control and author the related VP, CS, IQ, OQ and PQ documentation
IT Manager for Quality System
Molecular Templates
06.2020 - 04.2023
- As Department Lead, I was responsible to ensure we establish and maintain the validated state of the system for the Business
- Conducted a detailed analysis of current system to classify them into the correct GAMP level thus assigned the appropriate validation required
- I have worked with my Global Quality Assurance(GQA) organization to determine this categorization
- Was involved in the GxP gap analysis on the identified GXP systems
- This involves understand the GxP regulations like Electronic Records and Electronic Signatures( ERES), CFR 21 Part 11, Annex 15 and Data Integrity (DI) requirements
- As we are moving to a more risk-based validation, the team assesses the validation approach and risk
- Based on that a determination is made to the best validation approach
- The validation plan then looks at the set of documentation that will be needed as per the risk assessed
- Team then authors the required documents for the Computer Systems Validation (CSV) and moves them to approval
- As the lead for the QA and QC IT department, it was my responsibility to maintain the business systems to ensure their high productivity
- The business needed Document Control process urgently
- Since a product was already purchased, I quickly gathered the requirements, built a prototype and refined
- Since the Business was new to CSV, I provided training on Validation process
- Have written the required IT SOPs for CSV, trained IT staff on the use of the SOPs
- Worked with QA to conduct system audits to ensure we had good processes in place to maintain a validated state for systems
- The business also needed the processes for managing Non-Compliance, CAPA, Lab Exceptions while getting ready for a commercial stage
- As the SME on QMS process tools, I conducted workshops and focussed session to gather the requirements and help define the process
- Complete the Validation documents for the project
- As the company was transitioning to a commercial setup, I was instrumental in determining the scope of validation of the Infrastructure level as systems were being implemented, for both COTS and SaaS products
- As a department lead, had vendor management as a important task that included contract negotiation and MSAs
- As we moved to SaaS model for software capabilities, identifying the vendor Validation process and documentation became critical
- Have participated in the assessment of vendor documents
- Have worked in ensuring the vendor provided software validation support as the product goes through its lifecycle stages
- Successfully implemented tools like DocuSign, Q-Pulse EDMS, Matrix LIMS , Absorb LMS in less than two years
- Build a responsive and agile service team
- Applied good risk assessment methods to CSV tasks
- Brought good Project Management practices to deliver value to the business
Sr. Manager (Project Manager)
Cognizant
11.2014 - 06.2020
- Company Overview: (Amgen, Alcon, Thermo Fisher, PepsiCo, Amtrak, Mattel as IT Consultant)
- As Project manager in an Agile project, lead 6-member team to achieve the MVP goals
- As the client facing manager, I always strived to provide the business partners the most accurate information, ensure we discuss the achievements, bring forth the current road blocks
- Chaired the daily stand-up meetings
- Stakeholder management was large part of my job
- This included identifying the key success factors and critical pain points
- I focused on human relationships too
- Open and honest communication with my client was important to me
- This allowed me to build trust with my Business Partners
- As a Technical SME for QMS system, I was instrumental in collecting the most accurate and relevant requirements of the business, document them clearly
- Ensured that there was robust Scope Management to minimize changes downstream
- I have led the design sessions with my off-shore development to explain the design considerations that need to be accounted for
- Liaison with QA users to clarify requirements and provide them with the best practices in the industry
- Also, supported the Validation team in the validation scope and strategy
- Have authored validation Plan and Test Plan documents
- While preparing for the testing, have worked with the validation to author the Installation Qualification and Operational Qualification test scripts
- I have authored manual test scripts and also authored scripts in HP ALM system
- I have experience in executing manual scripts and also in HP ALM
- During the rollout of new process flows, deployment management included providing effective support to Training departments in executing the requisite training to end users and power users
- I have read the relevant predicate rules to interpret them in the IT situation
- Having read the GAMP5 rules, I have applied the risk factors to software changes to determine the amount of validation effort required
- The overall goal was to reduce the validation burden but also maintain a robust validation integrity
- (Amgen, Alcon, Thermo Fisher, PepsiCo, Amtrak, Mattel as IT Consultant)
- Successfully, upgrade the supplier inventory ordering system for a leading retailer
- Established good Agile practice for a leading Railroad company as part of their mobile application build
- Successfully rolled out 15 new workflow processes across the globe for a leading CMO
- Successfully upgraded the client software system including moving the data and build a new infrastructure
- Brought good Change Management practice to the manage the regular updates to business process
Manager, Business Information, Project
Leading Biotech
03.2004 - 07.2014
- Company Overview: (Biogen)
- As the system owner for the QMS platform, I have worked on multiple Internal Audits that review the robustness of Validation processes
- I have conducted investigations to identify root causes for audit findings
- As the owner of CAPAs, I have conducted Effectiveness Verification of the changes made as part of the CAPAs
- As a new analyst for Trackwise, I worked hard to understand the tool inside out
- Worked on the changes requested to gain knowledge of the system
- Identified the risks and challenges of the system to determine the appropriate level of testing of the system
- As the lead for the Trackwsie platform, I was instrumental in building a good methodology for collecting requirements that helps user to define them better and IT to gather them correctly
- As we implemented new processes, I was fully involved in the Organizational Change Management
- We strategized on the methodology of implementing the new process, identified the concerns that our audience had, provided multiple avenues to seek and get help with the new process
- As I implemented many different processes in the Trackwise tool, I applied good project management practices into the tasks being performed
- In order that we roll out the enhancements in a timely manner, I have worked in identifying the risk involved in the change, prioritize them and build the testing around the biggest risks
- I have authored all the validation documents from Validation Plan, Requirements Specification, Design Specs, Test Plan and IQ/OQ/PQ scripts
- As I started to manage the projects, I spent time to build a successful implementation team of developers and validation testers
- As Business Information Manager my primary responsibility was to investigate the current capability of the systems, identify the future needs of the QA department
- I then researched for solutions that would meet the current needs and fits well with our technology stack
- (Biogen)
- Implemented a PLM project to effectively regulate the release of new SKUs in Oracle PLM
- Redesigned and drastically improved the Change Management process in Trackwise
- Completed a business process re-engineering for the Quality process like Deviations, CAPA, OOS, Metrology Events, etc
- Successfully upgraded the Documentum EDMS tool
- Built a cohesive team to deliver exceptional service to my business partners
- Was successful in transforming culture of the team to a professional project management practice
Programmer/Analyst
Global Pharma
01.2002 - 01.2004
- Company Overview: (Pfizer)
- Working as a consultant for Pfizer’s Animal Health Group (AHG), provided ETL expertise to migrate data from its legacy Drug Safety system to latest system, AEGIS to PV Works
- Conducted a details analysis of the Business process to understand the data and its structure
- The process involved mapping the screens of two systems to the level of fields
- Analysed the tables to identify the columns that shall hold the legacy data
- Applied the business knowledge to map the columns and transform the data where needed
- Wrote efficient code that was robust, repeatable, and also easily tweaked to achieve any different load patterns
- Working as a consultant to Pfizer for its Development Science Informatics business unit, providing desk side support for Production
- When Pfizer needed to maintain its automated Drug Safety Evaluation applications, as the lead in the team I had to bring considerable expertise in planning and deploying new releases
- As Pfizer bought a new system to better analyse its research data, a need arose to integrate the existing applications with the newly acquired system
- Gather the requirements, analyse the issues, design the integration layer and also implement it
- Utilized Oracle technologies to build Forms and Reports with extensive PL/SQL code to integrate the data acquisition tool to application
- (Pfizer)
Education
Master of Technology - Control Systems
Benaras Hindu University
Bachelor of Technology - Electrical & Electronics
Kerala University
Skills
- PMP
- ORACLE DB
- PL/SQL
- SQL
- Web service
- Crystal Reports
- Java
- ETL
- OBIEE
- EDI
- JIRA
- ITSM
- ITIL
- TrackWise
- GAMP 5
- CGMP
- CGLP
- GxP
- Project Management
- CSV
- 21CFR Part 11
- LMS
- EDMS
- Oracle PLM
- LIMS
- HPLC
- ELN
- Q-Pulse Quality Suite
- Absorb LMS
- Matrix Gemini LIMS
- DocuSign
- Blue Mountain RAM4( CMMS)
- SharePoint
- Pharmacovigilance
- Veeva
- EQMS
- QC Labs
- Documentum
- PLM
- Power BI
- ERES
- DI
- GxP Gap Analysis
- System and Process Audits
- Business analysis
- Agile methodology
- Project management
- IT risk management
- IT vendor management
- Data analytics
- Application development
- Software development
- IT compliance
- IT system development
- Project lifecycle management
- Project leadership
- Requirements analysis
- Project planning
- Problem-solving
- Business process improvement
- Data analysis
Certification
- Certification in Applied Project Management, Boston University
- Certification in Lean Six Sigma process at Green Belt level
- Certified on TrackWise for Advanced Configuration
- Certified Project Management Associate from PMI
- Master of Technology in Control Systems from Benaras Hindu University, Varanasi, India
- Bachelor of Technology in Electrical & Electronics from Kerala University, Trivandrum, India
Training
- CONVOY
- SQR
- Oracle Manufacturing 10.7
- Usability Engineering
- Sybase 11.0
- Visual Basic 5.0
- Visual C++ 4.2
- Object Oriented Programming in C++
- SEI-CMM Level 3 In-Depth Training
- Usage on Function Point Analysis
- Developer 2000/Oracle 7.3
- Statistical Quality Control and ISO 9001 Standards
- Performance Tuning of SQL
- Java Programming Fundamentals
Achievementawards
- Awarded the Best Team Award for year 1997
- Awarded Special Achievement Award (Cash Bonus) for year 2000, 2006, 2009, 2011
- Appreciated (excellent feedback) for the contribution to support team for year 2001
- Appreciated for the contribution in holding the project together during staff attrition in 2003
- Acknowledged for performance exceeding expectation in 2005, 2007, 2009, 2012, 2015, 2016, 2017
Timeline
IT Consultant – GxP Systems
Sage Therapeutics
06.2023 - Current
IT Manager for Quality System
Molecular Templates
06.2020 - 04.2023
Sr. Manager (Project Manager)
Cognizant
11.2014 - 06.2020
Manager, Business Information, Project
Leading Biotech
03.2004 - 07.2014
Programmer/Analyst
Global Pharma
01.2002 - 01.2004
Bachelor of Technology - Electrical & Electronics
Kerala University
Master of Technology - Control Systems
Benaras Hindu University
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