SUMMARY:

• Self - motivated, results oriented and insightful Test Program Manager, Computerized System Validation Manager and QA Manager with strong Leadership, Project Management, Consulting and Process Improvement Experience who undertakes complex assignments, meets deadlines, manages client expectations and delivers superior performances.
• Test Management
• Computerized System Validation
• Project Management
• Test Automation
• GxP, Quality Management System
• Stakeholder management
• SDLC/STLC, s/w QA
• GAMP, Risk Based Validation
• Business Development
• Non-Functional Testing
• IQ/OQ/PQ, Change/Incident Mgmt.
• Project/Program Delivery15 years of progressive IT Services experience with expertise in Project/Program Management, Test Management, Computerized System Validation, Project Deliverables, Process Improvement, Risk Management, and stakeholders’ management.
• Extensive project/program/account management experience involving activities like client interactions, budgeting, staffing, hiring and development of testing and validation teams, defining processes/methodologies, deployment of best practices, schedule and monitor deliverables, knowledge sharing and cross functional activities at Program/Project level, presales, anchoring new proposals and participate in customer orals.
• Experience in Healthcare and Life Science domain with large independent testing & validation engagement across USA, UK, Central Europe and APAC. Successfully executed and managed large and complex programs through effective scope management, demand management, resource management, optimum resource utilization, reporting and through continuous drive on Innovation and process improvements.
• Managed end to end validation activities for various systems belong to R&D, Pharmacovigilance, Clinical area that comes under regulatory (GxP) purview.
• Strong experience in SDLC & STLC and implementation of various Legacy systems & COTs system in Healthcare and Life Science domain like Track wise, Documentum, Veeva, LIMS, LMS, CTMS, etc.
• Extensive experience of working with distributed global teams, onsite-offshore model and various engagement model like TCOE, MTC/MTS and independent QA.
• Hands on Experience in creating and reviewing full set of documentation involved in Computerized System Validation Life Cycle Including; User/Functional Requirements Specification, Design and Configuration Specifications, Validation/Qualification Plan, Risk Assessment (FMEA), Test strategy, ST/UAT Test, IQ/OQ/PQ Plan, Scripts, Summary Reports, SOPs and Validation/Qualification report.
• Proficient in using Testing tools like HPQC/HP ALM, JIRA, ClearQuest, UFT, Selenium, Work soft, Load runner etc.
• In-depth experience in SDLC/STLC test activities like Test estimation, Test planning, Test Strategy, Test Data management, Non-functional testing, Test Automation, Performance Testing, Test design, Test execution, Defect Management and Test summary reporting.

PROFESSIONAL EXPERIENCE:

Confidential

Project Manager

Responsibilities:

• Succeeding Cognizant engagement with Johnson & Johnson offering testing and validation services for enterprise applications like Service Now, HPALM, Solution Manager, GRC, SAP ILM, JIRA, Selenium, work soft, Sprinter, EDMS, SDDC, eGRC, LMS etc. that comer under regulatory (GxP) purview.
• Leading and managing testing and validation activities in synchronization with project scope, schedule, business objectives, interpretation of applicable federal and international regulations, industry standards, internal control and guidelines that pertain to the validation of GxP system.
• Lead and support new business development with drafting RFI/RFP responses, solution design, estimation, resource planning, governance model, communication plan etc.
• Ensuring Cognizant business targets are attained for Johnson & Johnson engagement and put up a strong foundation for future business executing projects/programs with flawless delivery. Make sure all future business opportunities are identified, evaluated and channeled appropriately.
• Understand the testing and validation activities to be executed for existing and new project/program. Articulate testing and validation strategy, estimate efforts, resource planning, staffing, and resource utilization based on project demands.
• Build a team of professionals (onsite + offshore) with appropriate skills, attitudes and motivation.
• Understanding of the key components and principles of a computerized system validation and auditor expectations.
• Ensure the team understand how the CSV process fits into SDLC and the purpose of each validation deliverable. Determine the need of and development needs of team members.
• Co-ordinate with customer team from various departments like Business, BUIT/IT, ISRM, RIM, Q-CSV in GxP Regulatory Assessment, Risk Assessment, Validation Planning and Validation Reporting.
• Ensure that project activities, validation deliverable and SDLC deliverable outlines in a compliance plan/validation plan are completed in accordance with define acceptance criteria and part of the validation package (Validation Plan, Risk Assessment, Protocols (IQ,OQ,PQ), Validation Testing, Incident Report, RTM and Validation Summary Report)
• Ensure the change management and other standard operating procedure are being followed to maintain the application in validated state thought the system life cycle.
• Track and prepare the report of testing activities like testing results, test case coverage, defects encountered and their resolution status, etc.
• Collaborate with customer’s internal and external partners, vendors, contractors, as required to meet dynamic needs of testing and validation resources.
• Participate in hiring process including conducting interviews and making hiring recommendations/ decisions.
• Ensure cognizant internal capabilities/tools (like test case generation, automation framework, performance testing, electronic signature etc.) are evaluated based on client potential usage and are leverage to generate non-linear revenue.
• Played a key role in starting first independent testing and validation engagement of Cognizant with GSK (in UK) and with Novo Nordisk (in Denmark). Established strong foundation in these two engagements to tap future business for cognizant in area of software testing and validation. I was responsible for onsite/offshore project delivery, managing customer expectation, issues and risks handling & project management.
• Novo Nordisk was replacing GCC and COCPIT (Legacy systems) with a standard configurable complaint handling workflow system The CCGloW system (For pharmacovigilance) consists of a configurable software platform based upon the EtQ Reliance Software Package Version 8.0c provided by the supplier EtQ. The CCGloW system interfaces to six other supporting systems like Argus, Siebel, LIMS, etc.
• Strategically planned the project activities, estimated effort, prepared the schedule and ensured the deliverables are on schedule and as per the defined SOW, scope, and quality standards.
• Understand testing & validation scope and need for overall project implementation.
• Manage onsite team for Functional, Automation and Performance test track and coordination with offshore counterpart from all these three tracks.
• Preparation of validation deliverables like protocol and summary report in line with established Validation Master Plan and Validation Plan by customer team
• SIT test plan include functional, automation and performance test
• Test Design and Test Execution of SIT for Manual, Automation and Performance test.
• Ensure adequate test coverage based on risk assessment output and complete requirement traceability during SIT and Qualification.
• Defect handling and coordination with customer and development team.
• Coordination with customer project manager and QA for review and approval of deliverables.
• Conducted periodic reviews of projects to identify the risks and ensured the mitigation plan
• Test Plan and Test Lab management using HP QC
• Support customer team during UAT and PQ.
• Serving Cognizant Life Science Testing & Validation practice was responsible to manage offshore project deliverables for testing and validation of various applications belongs to R&D, Manufacturing, Sales & marketing division of Merck pharmaceutical.
• Played a key role in starting first validation engagement of Cognizant with Lupin Pharmaceutical in Mumbai for its SAP system validation. SAP ECC 6.0 system is validated as it contains data necessary for the manufacture and distribution of pharmaceutical products.
• Understand testing & validation scope and need for overall project implementation.
• Assessment of the system to qualify for Regulatory Compliance.
• Assist and review the Functional Risk Assessment (FRA) to determine the requirements/modules with GxP impact.
• Establish validation end to end process for SAP ECC 6.0 implementation.
• Test Design and Test Execution of SIT for Manual, Automation and Performance test.
• Ensure adequate test coverage based on risk assessment output and complete requirement traceability during SIT and Qualification.
• Preparation of validation plan, OQ and PQ protocol.
• Review of OQ and PQ test results from GxP perspective.
• Ensure appropriate review and approval of validation deliverables.
• Bottom-line responsibility for all validation deliverables.

Confidential

Test Analyst

Responsibilities:

• During this stint with Infosys Independent Validation and Verification (IV&V) Practice, was managing offshore project delivery for USA telecom Giant AT&T for their SAP system EPIC (Enterprise procurement and inventory control).
• EPIC is SAP implementation ensuring that customer orders for Lightspeed Customer Premise Equipment (CPE) are fulfilled effectively and efficiently. EPIC is integration of processes across AT&T's supply chain, creating efficiencies that result in revenue increases, cost decreases, shorter transaction cycles and increased opportunities.
• Hiring, staffing and on-boarding resources based on project requirements
• Interacting with various stake holders to devise testing scope, strategy, testing approach, roles and responsibilities.
• Analyze business requirements and interact/coordinate with SME and development team to convert business requirements into testable requirements.
• Refining and deploying testing strategy on regular basis based on project dynamics, timelines, dependencies and associated assumptions and risks.
• Devise and implement s, knowledge transfers plans across functional tracks while deploying testing strategy.
• Define defects tracking process after discussions and review with all stakeholders and running defects triage process on daily basis.
• Conduct feasibility of automation and propose automation solutions on regular basis with emphasize on associated ROI.
• Define best practices across project and coordinate process compliance audits on regular interval.
• Leading the team (peak size of 65+) on Daily defects status and Progress meetings
• Identifying Risks and Plan for mitigation.
• Preparation of Milestone Report (monthly) & Quality Metrics Report (Quarterly).
• Project Staffing, Allocation, Billing, Activity/Effort Confirmation, Invoice.
• Also involved occasionally in responding RFI/RFP & Case study preparation

Team Lead

Responsibilities:

• Analyzed business processes, Performed comprehensive systems study and developed Requirements Specification Document.
• Supervised SDLC phases for various application systems designed and developed to meet business requirements.
• Detail Study and Analysis of System Requirement Specification.
• Feedback to Development team for product improvement and usability.
• Product Controls for change management.

• Quality Policies, Processes and Standards.
• Defining and capturing Test measurements.
• Establishing process goals, Benchmarking, Product Release Management.
• Product /Product Labeling.
• Setting up policies and procedures for QA.

• Test Strategy, Test Planning, Test specification, executions, ownership of defect life cycle, Test Reporting.
• Resource allocation (People, Hardware, Software and Facilities) & Identification of roles and responsibilities
• Project Controls using project management tools
• Directing, supervising and assessing individual’s performance.
• Giving feedback to Management & Implementation Head for each deliverable
• Mentoring team members. Lead a team of approximately 12 QA team members.
• Heading an energetic group in implementing ISO 19345 throughout QA and Customer Support teams.
• Authored software documentation including system overviews and user guides.