Experience in Information Technology as Document Control Specialist
*Experience in validating computer applications, Databases in accordance with 21 CFR Part 11 and GxP regulations.
*Highly proficient with all the phases of SDLC (System Development Life Cycle) process, and GRC (Governance, risk management and compliance ) validation methodologies
*Experienced in guiding the project team in delivering validation deliverables
*Experience in communicating with Project Teams (Technical, Quality and Compliance): project timeline, creating deliverables, user trainings, testing, issues and problem solving
*Ability to work well independently and in a team environment. Expert level of knowledge and understanding of SDLC and GRC validation methodologies.
*Qualification of Infrastructure components according to company standards.
*Validated Electronic Document Management system (Documentum) v3 and v4, Learning Management System v3, Trackwise v3 and v5, GIDS, and MCAS 6.0
*Expert in Document Management (Documentum, CARA) electronic document management system
*Expert in Change Management (Trackwise)
*Data migration process from legacy systems into Documentum (Wyeth and Hospira)
*Expert in creating, and reviewing validation documents in accordance with company policies and procedures.
*Validation Deliverables: Validation Plan, Verification Strategy Document (VSD), Business Integration Model (BIM) flow charts, Exception/Deviations, Verification Completion Report, Validation Summary Reports and various site deliverables
*Requirement Traceability Matrix (RTM) (Design specs, Functional Specs)
*Developed SOPs for Change Control System, Exception Deviations, Periodic Review and Documentum
*Expert in Creating, Reviewing and executing IQ/OQ/PQ paper format
*Expert in Creating Reviewing Use Cases, Test Cases, Defects in HP Quality Center (Automated Testing)
*Expert in Regression Testing and Performance Testing
*Periodic Review of Applications and User Access Review
*Guided project teams to conduct periodic reviews and how to gather the elements of PR
*Decommissioning computer application
*Audit experience of Databases and Servers within Continuous Monitoring process
*Effective communication skills to communicate between all organization levels
*Good knowledge of 21 CFR Part11, and concepts of validation
Operating Systems: Windows 95/98/2000/NT
RDBMS: Oracle, SQL
Applications/Servers: Documentum, HP Quality Center, Trackwise, LMS, SharePoint
Office Tools: MS-Office, MS-Word, MS-Excel, Power Point
Others: MS Visio, CMDB
FDA cGMP's Computer System Validation and 21 CFR part 11, QA Edge, PA USA.
Documentation and Computer System Validation, Pfizer NJ, USA.
HPLC and GC Applications Program, American Institute of Pharmaceutical Technologies, NJ, USA.
Document Control Specialist / CSV Specialist11/2006 to 08/2017PfizerPeapack, NJ
Migrate Hospira repositories into Pfizer Document Management System (PDOCS) repository.
Developed Core Data Migration Plan.
Developed Site deliverables (Validation Strategy Document, Data Migration Verification, VCR).
Developed Use Cases User and Functional Requirements using GRC Methodology and Procedures in HP Quality Center.
Reviewed and routed all validation deliverables using PDOCS (Documentum) for Project Team review and Approvals.
Developed Test Cases and Test Sets for Testing in HP Quality Center for testing migration.
Meetings with Project Team (Development Team and Quality) to discuss project timeline, requirements, and to assign Criticality and System classification to the requirements for establishing the rigor of verification.
Verification of Migration Tools (TRU Migrate and TRU Compare).
Created Test Steps for IQ/OQ Configuring Documentum (CARA) sites in HP Quality Center.
eApprover in HPQC, created accounts for testers and approvers.
Release Manager05/2006 to 10/2006WyethAndover, MA
Created Releases for each Test Run within HPQC for tracking purpose.
Involved in Data Migration End-to-End testing including executing the test and writing the Test Analysis Report for Data Migration End-to-End System Test.
Managed Defects during Iterative Testing and Final testing.