Summary

• Over 9years of strong Software Management, Quality Assurance, Training, Testing and Validation experience in Pharmaceutical/CMMI companies.
• Extensive experience working as a Validation lead for FDA regulated, mission critical GXP IT Systems in the Global Solution delivery model (Offshore- Onshore).
• Vast Knowledge of GXP (Good Manufacturing/Clinical Practices), GAMP, CFR 21 Part 11 and ICH & ISO Standards.
• Vast experience of Pharmaceutical Manufacturing, Clinical Trial, Drug Development and Safety, Marketing & Medical Affairs IT process.
• Expert in defining and re-modeling IT processes like Change control Management, Configuration Management, Standard Operating Procedures (SOP’s), System Retirements, Periodic Reviews, Disaster Recovery and Business Continuity Plan for large scale FDA Regulated IT systems.
• Experienced in providing quality consulting to several Pharmaceutical companies for their in house products and processes.
• Expert in writing Validation Plan, Requirement Specification, Functional Specification, Design & System Overview document, Test plan, Test scripts (automated and manual), Traceability matrix, Test Summary report and Validation Summary report.
• Experienced in providing training to the IT, business staff and external clients on the Quality process as Change Management, Problem Management, Software Development Life Cycle (SDLC), and Risk Management.
• Experienced in creating and presenting quality and test metrics/reports to the business partners and senior management team.
• Experienced in devising & reporting Service Level Agreements (ex. First time right, on time delivery) to Business partners, Infrastructure support group and outsourced vendors.
• Experienced in providing quality and guidance training to the team members.
• Experienced in applying Lean Six Sigma Methodology within a project for process improvement.
• Experienced in internal and external auditing of validation documentation and processes.
• Effective Team Lead with excellent communication skills in group meetings, and presentations.
• Highly motivated, quick learner, detail oriented, has ability to work independently and as a part of the team with Excellent Management, Analytical, Organizational, Communication and Presentation skills.

Education and Certification

• Bachelor of Engineering in Computer Science
• Certified Software Quality Analyst (CSQA)
• Six Sigma White Belt Certificate
• Currently working on Six Sigma Green Belt certification

Certified Training and Work Shop Attended

• Requirement Engineering, System design Overview Testing and Debugging Technology
• CMMI (Capability Maturity Model Integration)
• Verbal/Written Business Communications
• Problem Management and Leadership
• Overview of the Drug Development Process
• Guidance Overview – eIND, eNDA, eBLA
• Regulatory Industry Training(Overview of CTD/eCTD Guidance & Pharmaceutical Companies Organization and Submission Planning

Tools/ Technology 
Testing and Validation Test Director, Win Runner, Quick Test Professional
Application Development Lotus Domino Designer
Configuration Management Rational Clear Case, Microsoft VSS, WebTop, SharePoint, Documentum 
Languages and frame works Lotus Scripts, Lotus Formula Language, Java script, Visual Basic, SQL, TSL, HTML, XML, .Net
Change Control Management ARS Remedy, 
Defect Management Rational Clear Quest, Test Director
RDBMS/DBMS and Tools Oracle 11g, MS-Access, TOAD, SQL Server
Biotech Tools Trackwise, ARISg, eCTDXPress, ISIPublisher, Virtual Link Manager, ISIRender, ISIToolBox, ISIWriter, CRFTrack, ISIRegTrackerProject Planning MS Project

PROFESSIONAL EXPERIENCE

Company: Confidential Apr 2009 – Current
Client: Several Pharmaceutical Companies 
Position: Sr. Validation Lead

Project Description & Environment: 
eCTDXPress, ISIPublisher, ISIWriter, Virtual Link Manager, ISIRender, ISIToolBox, ISIWriter, CRFTrack, ISIRegTracker, First Doc, Documentum, SharePoint
CSC/ISI is a recognized leader in the area of electronic submissions of New Drug Applications (NDA\'s). CSC/ISI has assisted many of the world\'s foremost pharmaceutical companies in reducing the time and cost associated with eNDA development, compilation, submission, and review by designing, developing, implementing, and supporting advanced imaging tech.
Responsibilities:

• Verified and validated complex business and regulatory rules for submitting the Common Technical Documents to Regulatory Authorities for US, Japan, Canada and Several EU countries.
• Interacted with Business Sponsors, Project Managers and other internal department heads to identify Business Process relevant for delivering the Validation Packages to the several pharmaceutical clients for in house product releases.
• Lead and managed implementation and validation of CSC-RSG/ISI products for several pharmaceutical companies.
• Provided several internal and client trainings on QA processes and CSC Products
• Implemented Risk based validation to reduce cost and time required to qualify hot fix releases of the CSC/ISI internal products.
• Prepared Master Validation Plan, Test Strategy/Plan, Change Control Plan, Test Scripts/Cases, Test Summary Report and Validation Report for several internal and external pharmaceutical client projects.
• Executed Installation Qualification (IQs), Operation Qualification (OQs) and Performance Qualification (PQs) for different releases of the CSC-RSG/ISI products.
• Performed Quality review, internal audits of validation documentation and processes and participate in external client audits.
• Delivered eCTDXPress, Publisher and other regulatory products end user training to several pharmaceutical companies.
• Defined SOPs and Job aids as per the QA standards to streamline the quality documentation and execution processes.
• Trained, directed and coordinated work with offshore team to reduce the cost associated with the release testing.

Company: Confidential Oct 2007 – Apr 2009
Client: Confidential, USA 
Position: Validation/QA Lead

Project Description & Environment: ARIS global, Oracle, PL/SQL, Toad, MS Office Professional Suite, MS Project, Windows XP & Unix platform
ARISg is a Commercial Off the Shelf (COTS) system used by the Pharamacovigilance /Drug Safety department of the Eisai. The project calls for Support and Enhancements of various FDA regulated, mission critical Pharmaceutical Medical Services/Drug Safety & Medical Affairs/Clinical Trial Systems.
Responsibilities:

• Lead the validation activities involved in the merger of complex US and EU regional Adverse Event/Drug Safety data and business rules for reporting the Adverse Event to the Regulated Authorities.
• Developed QA standards, methodologies and defined the validation strategy to be followed in understanding, documenting and testing the complex business rules.
• Prepared Validation Plan, Test Strategy/Plan, Test Scripts/Cases, Test Summary Report, User Acceptance Check List and Validation Summary Report.
• Interacted with different groups within Medical Affairs and Medical Services groups to understand the dependability and data flow.
• Organized the Team Meetings and provided the Status Report to higher management on weekly basis.
• Coordinate with Team of developers and Testers (Overall team strength 6).

Company: Confidentiales Jan 2004– Oct 2007
Client: Confidential, USA 
Position: Team Lead/Offshore Coordinator
Project Description & Environment: Oracle, PL/SQL, Java Script, Lotus Notes, Domino Designer, Rational Clear Case, Rational Clear Quest, WebTop, Global Electronic Library- GEL(Customized document management system over Documentum) Test Director 7.0, Remedy, MS Office Professional Suite, MS Project, Windows XP & Unix platform.
The project calls for Support and Enhancements of various FDA regulated, mission critical Pharmaceutical Manufacturing IT Systems that include Trackwise CAPA, Global Incident Management System, Global Change Management System, Packaging and Engineering Applications, MARS/Maximo. 
Responsibilities:

• Interacted with Business Sponsor, Project Manager, Functional Lead and Development Lead to identify Business Process relevant for several projects.
• Performed Change and Problem Management for various complex GXP manufacturing IT applications using Remedy Tool.
• Provided SLA Reports, Exception Reports, Causal analysis using Remedy.
• Provided WSR (Weekly Status Report) and MSR (Monthly Status Report).
• Performed Defect and Configuration Management using Rational Clear Quest/Case.
• Utilized Test Director to create the test plans, store the test cases, run the test sets and report the defects.
• Single Point of Contact for all the support related activities for various business critical applications.
• Lead and managed multiple business critical projects without any supervision.
• Provided real time assistance to the end users of Manufacturing.
• Participated as core team member in Six Sigma Project to reduce the Change Request completion time for MARS/Maximo application.
• Coordinated with Team of developers and Testers (Overall team strength 13).
• Managed the work statement and performance evaluation of the team members both at onshore (USA Team) and offshore (India Team).

Company: Confidential Feb 2003-Dec 2003
Client: Confidential 
Position: System Analyst
Project Description & Environment: The core objectives of the project are to undertake maintenance & support of IB Rates applications of JP Morgan Chase in a cost effective and quality-oriented manner.
Environment: Test Director, Lotus Notes, Domino Designer, Visual Source Safe

Company: Confidential Jul 2002 –Jan 2003
Client: Confidential 
Position: Team Member
Project Description: Web Trade has a Groupware division, which develops solutions for Web and Lotus Notes requirements for the internal purpose. This group was responsible for the development of Training Administration System (TAS) and Library Management System (LMS) applications.
Environment: Lotus Notes, Domino, Domino Designer, Visual Source Safe