- A dynamic professional with over 15 years of experience as Technical Project Manager / Project Lead / Software Developer / System Analyst / Business Analyst
- Extensive experience in Pharmaceutical and Financial industry
- Experience in developing and reviewing Validation Protocols: Installation, Operational and User Acceptance Testing (IQ, OQ and UAT) and writing Standard Operating Procedures (SOP).
- Excellent understanding of the Validation Development Lifecycle (VDLC), QA Methodologies and GxP Assessments.
- Expert knowledge of FDA 21CFR Part 11: Electronic records and Electronic Signatures.
- Excellent knowledge of Global Regulatory Operations (EU, US and Canada)
- 10+ years of experience in Analysis, Design, Development, Implementation, Maintenance and Enhancement of Lotus Notes / Domino applications.
- As a Senior Technologist posses a variety of skills in the IT industry with a specialization in project management of enterprise applications development and deployment
- Direct client interaction to ensure high quality project planning and implementation with follow-up for process optimization. Excellent analytical, organizational and communications skills.
- Proven track record of managing multiple projects of varied complexity.
- Decisive Manager with extensive experience in gathering requirements and translating needs into efficient system and business solutions. Self-motivated and reliable, consistently seeking increased levels of responsibility as a leader, team member and individual contributor. Ability to lead and interact with a diverse group of individuals
- Extensive experience with system development life cycle (SDLC).
- Suitable for dual role play as Technical Project Manager / Solution Architect
Languages: Lotus Script, Notes Formula, Java Script, VB Script, HTML, XML, PHP,SQL, CSS, RDBMS: Oracle 7.x/8/9i, DB2, My SQL, SQL
Groupware: Lotus Notes / Domino R 8.x / R6.0x / R 5.x / R 4.x, Sametime, QuickPlace (Quickr), Domino.Doc
Middleware: LSX, LEI, DECS, ODBC
Graphics: Dreamweaver Mainframe Skills: COBOL, DB2 Operating Systems: MS-Dos, UNIX, Windows 95/98/NT/2000/XP/Vista/Windows 7 Other Tools: Team Studio Suite, Integra4Notes, ActivePDF, ScanToNotes, MS-Visio, MS Project, Excel Macros, MS Access QA Skills : Validation, IQ, OQ, PQ, UAT, Deficiency Report, Change Control, Summary Report
April 2004 to Till Date Confidential, New Jersey
Roles : Project Manager / Sr. Lotus Notes Consultant
- Responsible for delivery of projects firm-wide.
- Managed and delivered more than 10 projects on time, on budget, with highest quality, and high level of customer satisfaction
- Defined overall project plan, schedule and budget management, risk and issue management, facilitating product rollout, and status reporting.
- Project tracking across multiple projects.
- Ensured delivery of projects as per committed timelines and quality.
- Involved in gathering requirements, architecture, development and enhancement of application.
- Managed the Business Support and Production Support of various Lotus Notes / Domino based applications.
- Authoring of Project Charter, GxP Assessment and Validation Plan of all the application.
- Also involved in authoring of UFRS, TDS, IQ, OQ, Traceability Matrix and Validation Summary Report.
- Full understanding of 21 CFR Part 11 Compliance
Applications fully responsible: Global Regulatory Affairs Tracker :
- This database captures and stores detail product information and allows authorized users to access.
- The products are organized by region (Canada, EU and US) and also by type (eCTD and Non-eCTD)
- The system captures all information related to FDA Submissions and EU Health Authorities
- The system keeps tracking of all the tracking information and proof of delivery. It also links to the actual submissions from a secured shared folder.
- The system also contains the repository of all the correspondence from the health authorities.
- Sends alerts and notifications in real time via email about annual report due date and PSURs.
- Provides ad hoc reporting for management.
- Maintains all Certificate of Pharmaceutical Products.
- This system follows the GxP procedure.
Clinical Supply Shipment database is a repository of all drug shipment, release and receipt forms and return destruction forms. Unified Change Control database is a common process to collect, prioritizes, administer and manage IT Request for Changes throughout any IT supported systems. The system goes through the entire workflow of getting signatures from all the users involved in implementing the changes to the system. Lotus Notes / Domino 6.x, 7.x, 8.x, LEI, ActivePDF, Integra4Notes, MS Project, Visio, LEI.
July 2003 to March 2004 Confidential, New York
Role : Offshore / Onsite Coordinator
SelfServe (Benefits and Payroll)
- Involved in the Enhancement and Maintenance of this notes based application.
- Involved in the transition of this application from Onsite to Offshore.
- Identified an offshore resource and assigned the task.
- Ensured delivery of projects as per committed timelines and quality.
This application is developed as a one-stop shop for employee benefits. It consists of various modules like Benefits Summary, Dependent Summary, and Requests for Pay Advices, Retirement Statements, Annual Benefits Enrollment and Direct Deposit accounts. This Application uses ActivePDF to generate W-4 forms of individual employee with the users data pre filled. Extensive use of Lotus Script, Notes Formula languages , Script Libraries and all data¡¦s are stored in Lawson (Oracle) and accessed in lotus notes using DECS (To connect real time to Lawson) Lotus Notes 5.0.8, Domino 5.0.8, DECS, ActivePDF
December 2000 to August 2001 Confidential, New Jersey
Role : Sr. Notes Developer
September 1999 to August 2000 Confidential, Phoenix
Role : Programmer Analyst
Involved in Design, Development, Maintenance, Implementation and Quality Assurance of Client Folder database. Around 600 users use the database, with more than hundred thousand documents in the database. The database consists of 65 forms, 250 views and around 300 Agents. This database deals with AMEX financial data with respect to Card and Travel business of its various clients. The main function of the application is to generate a Profile form and its related sub form. The profile form basically consists of
customer information and their relation with AMEX. Depending on the relations, different documents are generated. The respective department leader views those documents and based upon certain standard criteria the document gets approved or rejected. The values for most of the fields in this form are inherited from the output of a Mainframe system, which comes to notes as a text file. These text files are extracted using an agent to write the values in the notes document. There are around 15 scheduled agents run every day for exporting the processed data\'s from notes database to a text file. The processed data\'s from these text files are again used by mainframe system to generate the overall report. There are different reports that are generated in notes environment depending on the relationship of the customer with the AMEX. The reports are generated using Lotus Script agents and are formatted in Excel spreadsheet. Domino 4.6, Lotus Notes 4.6, Windows 95/NT, Lotus Script, MS-Excel
March 1999 - August 1999 Confidential
Role : Programmer Lotus Notes
Administration: Responsible for the implementation of infrastructure design and administration of Lotus Notes servers. Performed server performance tuning. Provided support in controlling regular replications and statistics of pending mail and dead mail. Performed daily maintenance of Name and Address book. Maintained the pending corporate databases and application databases on the servers. Provided user support for installation and configuration of notes client. Involved in the move up of databases from test server to production environment. Responsible for testing the migration of Notes R4.5 to R5.0. Involved in the Installation and Configuration of Domino R5 server and Notes R5 client. Also involved in the Maintenance and Administration of all Notes database and also in Configuring SMTP mailbox.
Lotus Notes Development: I was also involved in the Design, Development, Testing and Implementation of Payroll Processing database using lotus notes and domino. The purpose of this application is to support the personnel department in calculating the wages of an employee on an hourly basis for a month. At the end of each month a scheduled agents gets triggered which retrieves data from the Access database (which stores data regarding attendance of the employee) through ODBC connectivity and calculates the wages according to the given conditions and creates an employee report and mails it to the personnel department. At the same time individual pay slips for the employees are also created and mailed to their respective mailbox. The agents are developed using Lotus Script and Notes Macro. Extensive use of Script Libraries, LEI (For updating data from SQL to Notes). Domino 5.0, Lotus Notes 5.0, Windows 95/NT, Lotus Script, MS-Access
August 1998 to March 1999 Confidential
Role : ProgrammerInvolved in Design, Development, Testing and Documentation of the following application. Also involved in the installation and configuration of Lotus Notes Client R4.6. Publishers Tracking System John Wiley & Sons(JWS), U.K.
The primary purpose of this tracking system is to enable John Wiley & Sons (JWS), U.K. And external typesetter to track the production of Encyclopedia of Analytical Chemistry (EAC) efficiently. It will allow both JWS and the external typesetter to actively update, in real-time, the progress of each article. The initial phase is called Editorial phase where the font size, color, and other attributes regarding the pages are set. Once the respective manager approves it, the document enters the Pre-Production phase where the author and typesetter details are set. In the production phase tracking system is able to track each individual component of the article and the flow of document among typesetters. At any point of phase there is an option to find where the document is pending for approval for inputs. This system also
April 1997 to August 1998 Confidential
Role : Jr. Programmer
Involved in the Design, Development and Testing of various applications for the organization and also involved in installation of Notes Client R4.5. Workorder Analysis Travel Request System Tourist Information Domino 4.6, Lotus Notes 4.6, Oracle, Window 95/NT, Lotus Script
- Masters in Computer Applications
- Post Graduate Diploma in Business Administration
- Bachelors in Mathematics