SUMMARY

• Highly motivated professional with 8 years of experience in catering to business needs in the life sciences and IT industry at various capacities as a project manager, business analyst and quality assurance engineer.
• Skilled at managing collaborations, managing programs/projects, creating new business opportunities and building innovative solutions by integrating technology and business processes, thus providing exceptional client services.
• Software implementation (eCTDXpress, VLM, ISI Publisher) experience in Life sciences industry for various pharmaceutical companies and Healthcare industry (Symphony HIMS).
• Business analysis experience in coordinating with cross functional team in delivering IT projects in Agile and waterfall methodologies.
• Software quality assurance experience in testing e - Commerce as well as information websites (Federal Project)
• Responded to RFPs and RFIs and won Regulatory affairs/operations projects worth US$1.6 M for the company with clients, Confidential & Confidential, Bristol Myers Squibb, and Otsuka pharmaceuticals.
• Created effective short and long term strategies and leveraged cross cultural negotiation skills and a collaborative work ethic to complete projects under tough deadlines and resource constraints.
• Combined a deep and core knowledge of the building blocks of industry with the strategic acumen to successfully execute projects. An entrepreneurial work ethic has led to creating new opportunities with the clientele in a niche industry while making a new profit making centre for the companies I worked for.
• End-to-end project management throughout the life cycle of a software/system development project/program
• Regulatory strategy consulting, publishing consulting for regulatory affairs/ operations projects, with in life sciences industry
• Software implementation within pharmaceutical industry through proper Installation Qualification (IQs), Operation Qualification (OQs) and Performance Qualification (PQs)
• Good Client services and customer engagement expertise, globally
• Analyzed, designed and developed test plans, test cases and test scripts
• Automation, testing of software in e-Commerce, life sciences, health care and Govt. Projects

TECHNICAL SKILLS

Languages: C, PL/SQL, VB scripting

Databases: Oracle 9g, 10i; SQL Server 2005

Life sciences Software: ISI Toolbox, eCTDXpress, ISIPublisher, Virtual Link Manager, ISIRegTracker, Freyr Submit, Freyr Label, Freyr Reg Insight

Software Tools Project management, Quality analysis and Business analysis: MS office, MS Project, MS dynamic CRM, Visio, Adobe Acrobat, PPT, QTP, Clear case, clear Quest, Rational Quality Manager, TPlan Robot

PROFESSIONAL EXPERIENCE

Confidential, PA

Project Manager

Responsibilities:

• Conducted As-is analysis of existing IT systems and applications at Jai pharma and prepared the IT readiness plan to Day 1 of integration ( Day 1-logical point where certain legal contracts for acquisition are signed)
• Planned the phase wise merger of various IT application and set the targets for the team after carefully considering all the constraints.
• Managing the PMO at Mylan for the IT integration projects and strategized effective communication plan for seamless integration
• Worked on the OpEX and CapEX budgeting for 2016 for IT
• Successfully closed all the Day 1 IT targets and achieved stability post Day 1.
• Further supported the Day 30 activities as per the plan and continued successful management of the project

Confidential, Whippany, NJ

Implementation Project manager

Responsibilities:

• The project tasks that were accomplished as an implementation consultant by Implementing the software eCTDXPress, ISI Publisher, VLM for pharmaceutical clients such as Novartis, Shire, J&J, Takeda, Benvenue, Cempra, Ivax, Savient, Akrimax etc. are:
• Provided gap analysis and define the scope of implementation
• Discuss architecture with the client for implementing the software
• Implemented Databases both SQL/Oracle relates to the software
• Conduct meetings to review the functional specs
• Strategic planning of the project and drafting necessary road map, installation qualification documents to implement the software on the client’s network
• Software Implementation, IT Validation according to compliance -GxP & 21 CFR Part 11, IT Quality assurance check and product release for Pharmaceutical and Biotech clients
• Created a test bed (test cases and test scripts) to perform complete operational qualification of the newly deployed software
• Monitored the effective use of applications (eCTDXPress, ISIPublsher and VLM) and technical infrastructure to ensure optimal performance and compliance with the company processes
• Built eCTDs such as the new drug applications (for US and EU regions)
• Conducted meeting with the business users and educated them on the software, Optimized plans to perform the full installation qualification and Operational qualification depending on their business need
• Worked on the data migration project to ensure transfer of data during the upgrade of the software.
• Created a test bed to perform complete operational qualification of the newly deployed software documents.
• Helped the Sales Engineers to market the product by conducting demos of the software to the client
• Project tasks involving regulatory operations:
• Supported the regulatory team by tagging STF for an eNDA application.
• Created hyperlinks and bookmarks within eCTD.
• Quality verification of the entire submission for avoiding broken hyperlinks.
• Create and maintain electronic and hard copies of various documents:
• SOPs, Work Instructions, Forms, Logs
• Product document Master Lists
• Templates (email, procedural, etc.)
• Process/Product flow charts

Confidential, Lansing, MI

Lead- Quality Assurance

Responsibilities:

• Analyzed, designed and developed test plans and test cases in Rational Quality Manager for testing MISACWIS
• Lead a team of 15 testers on test development and test execution effort for Functional, Integration, regression and Systems Testing
• Analyzed complex business scenarios in the use cases to form test plans of considerable complexity
• Established IT quality standards and IT best practices for the use of the “RUP” (Rational Unified Process) in test case and test script development.
• Adept in using Oracle PL SQL to query the test databases for information and thus solving issues that arise during testing of the software
• Ensured that all the plans made, documents drafted have met the IT Quality standards after performing a quality assurance check and then when ahead for client’s approval
• Provided analytical support to design and development teams during the course of the project
• Tracked the defects found in the software within “Rational Clear Quest”, during the testing phase and maintained the software testing life cycle for the defect identified
• Prioritized the defects identified according to the severity and escalated them for correction
• Conducted status and progress tracking meetings within the “Quality Control” department to discuss the progress and provided traceability to the software requirements that were tested
• Drafted “UAT” (User Acceptance Test) documentation and supervised UAT before the software was delivered to the client
• Performed quality assurance check of the software at each phase of the Software testing life cycle and ensured that the delivery is made according to the schedule
• Signed off on all major deliverables from Quality department, that ensured successful Quality assurance check of the software

Confidential, Warren, NJ

Business Analyst/ Project lead

Responsibilities:

• Lead a team of 15 offshore resources on the Automation testing project.
• Responsible for providing subject matter expertise and planning of the project
• Resource allocation for developing automation scripts and ensure timely delivery to the client
• Created technical documentation such as “Master validation plan” and “User acceptance test” document and assured the quality after conducting several meetings with the client to review the documents, before seeking final approval.
• Performed quality assurance check on the automated test code according to the IT quality standards in accordance with the Confidential protocol and finally uploaded it to share point site.
• Defined the scope, purpose and all the deliverables for the automation test effort.
• Implemented the Test platform for a web based application at Confidential and gave demos to the client at several stages.
• Lead business meetings during the requirement analysis. Created and optimized plan to form effective test plans and cases for the entire Media store website.
• Scripted and lead the team in scripting the T-plan robot test scripts for automation.
• Solely deployed the infrastructure after procurement, for client server architecture.
• Hosted several Meetings with the teams to coordinate the ongoing effort and to maintain clear communication within the group for the effective delivery of the scripts to the client.
• Supported the test platform in the production environment and creating the test bed for mobile apps testing
• Supported application implementation and technical aspects of projects with the business and IT colleagues to translate their demands into efficient, appropriate IT Solution.
• Developed close to 3500 test cases to test the website
• Resolved bugs found during the testing phase.
• Expertise on T-plan robot - scripting tool for automation of the test scripts.

Confidential

Program Lead

Responsibilities:

• Managed EU centralization program with a team of 25+ regulatory experts who were responsible for various services such as Dossier Preparation, Chemistry Manufacturing and control and publishing for the J&J EMEA (European Middle East and Africa) markets.
• Lead Over 15 projects (Including 4 months of onsite time at Confidential & Confidential office at Maidenhead, UK) focused on regulatory affairs and operations across the EMEA market, such as Dossier preparations for various regulatory filings, Chemistry Manufacturing and control variations, Global labeling operations XEVMPD submission publishing projects.
• Managed Operations at PMO (project management office) by conducting monthly meetings with all the stakeholders and providing metrics from various projects, while monitoring the progress of the projects.
• Involved in budget planning for the program, and managed the monthly cost tracking of the expenditure.
• Developing business processes to meet complex technical business requirements across a wide variety of operations.
• Led a research team in conducting market research for launching products in African countries.
• Experience in answering RFIs and RFPs for business development and Won projects worth US$1.6 M for the company with clients, Confidential & Confidential, Bristol Myers Squibb, Otsuka.
• Responsible for positive cash flow in the company (under present market conditions) generating pprox. $1 million dollars in revenue and creating a growth of 20% since Jul’2014.
• Redefined service methodology to capture the value chain (Increased the number of Regulatory operation projects) and develop business models for expanded long term growth.
• Implemented personnel training program and personally trained and mentored staff to cater to a niche industry’s standard and achieve a growing demand for business opportunities.
• Provided insights for in house product development for product such as: Frey Reg Insight, Freyr Label, Freyr Submit (Publishing tool).

Confidential

Manager- IT Applications

Responsibilities:

• Carried out process mapping exercise for both Macro & Micro level processes of the hospital
• Explored potential areas for IT application or Process automation
• To study the feasibility for executing the identified IT application or Process automation activity.
• Coordinated with Unit Quality Team & other hospital staff.
• Prepared a report detailing recommendation for the areas of IT application or process automation, responsibility matrix, implementation plan of action, time frame and submit to Principal Quality Officer
• Recommended corrective action plans and improvements in the resolution of non-compliance with standards detected through monitoring and auditing of processes and procedures.
• Tracked and present the data on before and after project implementation. To provide data on the improvements made in patient care and financial benefits to organization both qualitative and quantitatively.
• Coordinated with the “National Accreditation Board for Hospitals” quality audit inspections, reviewing systems, data and documentation to help the hospital renew the accreditation
• Involved in the execution of the project, after management’s approval