Management Project
Resume:
Ashwani Sharma (91-880*******)
PMP, ITILv* Certified, US Visa B1/B2
Project Management/ ITIL v3 Consultant/ Business Analyst Total Experience: 10+ Years
Email: *******.**@*****.***
DOB: 07-04-1983
Skill / Experience
Summary
PMP, ITILv3 Certified experienced Project Manager with over 10 years of experience Implementation and
Production Support, Business Analyst & Project
management.
Project Management Office– End to end project
Tracking, Client Communication, Business Development Planning, Team review and Appraisals, Team Audit,
Weekly/ Monthly Reporting, Risk Management.
Quality Analyst: Draft QA policies, Ensure Compliance, Implement SOPs, Sign SDLC documents and Change
Controls, faced internal and external audits.
Production Support &Maintenance: - Handled L2/L3 support processes – Incident, Problem & Change
management, Continuous service improvement.
Business Analyst – RFI, RFP, Requirement gathering via brainstorming, customer interviews, documentation.
Computer System Validation – End to End project
implementation and validation lifecycle.
Domain Consulting – Clinical Data Management,
Regulatory, Laboratory, Drug Development, Drug
Dictionary, Standards : ISO 9001, GAMP,GMP,21-CFR
part 11, GxP, iQMS etc
Process consultant – Incident Management, Problem Management, Change Management, Agile, Continuous
Service Improvement (CSI).
Documentation – Authoring Business requirements, System requirements, Test cases.
Trainer –ITIL processes, Soft Skills, Project
Management (PMP).
Tools – MS Visio, Oracle Applications- Life Sciences Data Hub, HP Quality Center, HP Service Center,
Remedy, Documentum, Empower, NuGenesis, Vision
Publisher, Oracle – OC, LSH, TMS, DEAR,
Documentum
Experience Profile – Key Projects
Project: Quality & Compliance/ Project Management (Aug 2013 – till Date) Customer Name: Sun Pharma Industries Limitied.
Project Description: Research Information group contains portfolio of IT applications which requires end to end Implementation or Support and Maintenance to provide solutions to RnD to save cost and time and responsible for managing Quality Projects. Projects – Bio Sample & Pharmacy Management System, Empower, NuGenesis, Vision Publisher, Oracle Clinical and Thesaurus Management System, eCTDExpress Role Description: Project Manager
Key Responsibilities included:
Project Implementation across enterprise by Project Management, Business Analysis, and System support of various applications.
Incident management and Change management – Evaluation, resolution, reporting
Responsible for end to end Vendor Management, Infrastructure Management, Change Management, Team management.
Investigate user issues, complaints and provide prompt resolution.
Faced and replied to queries during Regulatory Audits FDA etc. Project: Pfizer IT ERP Quality & Compliance (Oct 2011 – Aug2013) Customer Name: Pfizer Inc
Project Description: ERP SAP ECC 6.0 US Pharma Major's current ERP support framework to be integrated with Wyeth SAP modules. Role Description: Computer System Validation
Key Responsibilities included:
Computer System Validation for all change controls.
Author validation documents by referring/ updating SOPs & templates and prepare checklists instructions/ guidelines.
Analyse data to identify areas for improvement in the quality system.
Responsible for the Maintenance of the Quality Management System
Review of documents for Quality Management System
Manage all changes(GMP Change control) in accordance to the change management process.
Ensure SDLC traceability and created documentation to necessary detail. Project: IR Information Repository (Requirement Gathering) (April 2010 – Sep 2011) Customer name: Glaxo Smith Kline
Project Description: Business Requirement & System Requirement gathering, analysis and documentation for SCD- Simplified Clinical Development - Information Repository project for Life Sciences Data hub – Oracle Application Suite Role Description: Business Analyst and Project Management. Key Responsibilities Included:
Process development and requirement Gathering by communicating effectively with diverse stakeholders.
Creating and transforming business requirements into functional requirements and designing business models using UML diagrams - Context, Use Case, sequence, activity diagrams in MS Visio
Agree deliverables/milestones and report project progress to the stakeholders as per the process defined by the account.
Develop, recommend and monitor CAPAs.
Project Management reports– DSR, WSR, MSR report generation. Achievements:-
GEMS for Business Requirement gathering
Appreciation for Clinical Study Execution module GEMS for being a leading scorer for E1 LSH competency Project: Production Support - ICDS(Coding Dictionary) & PACE (Clinical Trials) (Oct 2006 – Feb 2010)
Customer name: Glaxo Smith Kline
Project Description: Production support & maintenance for be-spoke Clinical Data management applications including Coding dictionaries, Electronic data capture, Inform etc.
Role Description: Quality/ Support Analyst
Key Responsibilities included:
Quality Assurance & Control – Approval of change control from quality assurance perspective which involved tracking & rectifying anomalies and following up with stakeholders.
SDLC documents QA approvals in entire SDLC of the application wrt to a Change control eg BR, SR, DS, STC, TIP etc.
Monthly reporting and continuous service improvements based on the no of change controls and client feedback on service.
Conducted trainings & workshops on ITILv3 – IM, PM, CC etc. Achievements:-
Winner of Mahindra Satyam recognized Bravo award for the outstanding work in ITILv3.
Technology Experience
Summary
Application Support & Maintenance, MS Office and MS Visio, ERP- SAP Logistics & Distribution modules,
Oracle Applications Functional – LSH, TMS, OC
Domain Experience Drug Development Process, Clinical Data Management, Thesaurus Management System, Lab Information Manage System, Bioequivalence, GXP, iQMS
Professional Summary
Organization Year
Sun Pharmaceuticals, Gurgaon Aug’13 to Present
Tata Consultancy Services, Noida Apr 2010 – Aug 2013 Mahindra Satyam Oct 2006 – Mar 2010
Education Summary
Degree and Year Institute Major and Specialization Btech - 2006- 70% Amity, IP University Computer Science 12th – 2001- 75% DPS Science (CBSE)
10th – 1999 – 82% DPS CBSE
Professional Memberships / Certifications
Professional Society / Certification
PMP, ITIL v3
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