SUMMARY:

• I am presently working for a large pharmaceutical company as a Quality and Compliance Consultant.
• Career background in technology includes Validation, Quality Assurance, Quality Review, Verification and Testing.
• Created Confidential deliverables including Risk Assessment (RA), Validation Plan (VP), User Requirement Specification (URS), Functional Requirement Specification (FRS), Installation Qualification (IQ), Operational Qualification (OQ), System Configuration Specifications (SCS), Performance Qualification (PQ), Traceability Matrix (TM), and Validation Summary Report (VSR) following Confidential and other regulatory guidelines.
• Possess exceptional analytical, technical, interpersonal, communication and writing skills.
• Assume multiple project responsibilities, prioritizing the duties as per requirements and remaining productive within time - sensitive & fast-paced environments.

TECHNICAL SKILLS:

Software: SAP ECC, Insight Document Control, eRoom, Toad, MS Office, Lotus Notes, MS Outlook, MS Project, PVCS Tracker and Version Control, ClearQuest, EXTRA for Windows, SIR/MADAM defect tracking and reporting tool, eCabinet, Documentum, Citrix Xpe, and eProject application, eCabinet, Epic Star, Remedy, SharePoint, Atlassain’s JIRA software, CARA, Vitalize, Pilgrim (SmartSolve), Windchill PLM, Adaptive Document Control

Paperless Testing/Bug Tracking Tools: HP-ALM v12.0

EXPERIENCE:

IT Quality and Compliance Consultant

Confidential

Responsibilities:

• Managing various implementations of Veeva, Mobile Intelligence, In-house (Contact Management, Field Alert, Inquiry Management and Reporting modules for CRM GxP and Non GxP Projects utilizing PUMA methodology.
• Responsible for a new implementation of a BI 2.0 project as a quality lead ensuring appropriate testing of all data streams to create final golden records for reporting.
• Reviewing quality deliverables including System Criticality, Plans, Testing documentation, and Reports.
• Communicating quality guidelines with the project teams plus providing any updated quality process releases to various teams.
• Reviewing and Approving Change Tickets within Service Now application.
• Reviewing and Approving documentation within GeodIS (D2-Document Management System) and HP ALM applications.
• Reviewing and approving CAPAs for various items and actions.

Consultant

Confidential

Responsibilities:

• Validation project for Windchill - A medical device Product Lifecycle Management System upgrade from v10.1 to 11.0 utilizing Agile Methodology.
• Application was utilized by various business franchises for project management; lifecycle management and change management of CAx data, device models and related documents; and for managing and maintaining project deliverables, including Design History File (DHF) and Technical File (TF) records for medical devices.
• Utilized JIRA Software for project management.
• Assisted in translation of the old requirements into user stories.
• Created validation deliverables.

Consultant

Confidential

Responsibilities:

• Validation for SAP Upgrade to ECC 6.0, which included creation of validation deliverables including Compliance Plan, Compliance Report, Data Conversion and Migration Protocols and reports.
• Performed Quality reviews of System and UAT Test scripts including providing guidance of resolution of defects.
• Worked with business users and train them on UAT executions.
• Conducted weekly status meetings for management.

IT Validation Analyst

Confidential

Responsibilities:

• Validation for SAP ECC, SAP OER, and eMDM was performed to comply with Title II of DQSA (Drug Quality and Security Act) set forth by Confidential for transaction history, transaction information, and a transaction statement for the Rx drug product.
• Performed Risk Analysis and created validation deliverables
• Participated in the Drug Product Serialization Pilot program.
• Reviewed SOPs and various processes to comply with the regulatory change for DQSA, including ASNs via EDI, Training materials etc.
• Utilized Pilgrim- SmartSolve for approval of regulated documentation.

IT Validation Process Lead

Confidential

Responsibilities:

• Performed Gap Analysis to identify gaps in existing IT processes and procedures.
• Created IT Process for Regulated System governance at the company.
• Evaluated SaaS computing for regulated environment implementation.
• Created various procedures including but not limited to Risk Assessment, SLC, Confidential, and Change and Defect Management.

Validation Lead

Confidential

Responsibilities:

• Worked for the IT Validation Services as a Validation Lead, validating the software for various clients of Confidential .
• The Module implementations included SOP Management (Standard Operating Procedure), eTMF (Electronic Trial Management File), Quality Management System (QMS) and Regulatory EDMS solutions.
• The implementations included the baseline and customer specific customizations of the product on sites as well as cloud environment.
• Performed analysis of Requirements, Configurations and Design Specifications.
• Created Validation Plans, and Summary Reports.
• Performed quality reviews of System/UAT test scripts and Traceability Matrix.
• Reviewed all deliverables and coordinated the defect management effort with the client QA Teams for defect tracking and defect resolution.

Validation Lead

Confidential

Responsibilities:

• Worked for the IT Validation team to perform root-cause analysis on the defects encountered during a major release of EtQ a change management system.
• Coordinated the defect management effort with the QA Team to ensure accuracy of the defects including proper documentation of resolution.
• Performed quality reviews of validation deliverables including but not limited to Requirements, Design and testing documents.
• Ensured compliance of validation deliverables with company policies and SOPs.
• Coordinated with team members to ensure consistency across all test environments.

Validation Lead

Confidential

Responsibilities:

• Worked for the IT Validation team to lead the validation effort of a major release of CARA (Consolidated Authoring, Review and Approval) by Confidential Corp., a Production of Confidential Information and Submission Management system.
• The existing client server environment was replaced by the new web application, facilitating creation, review/approval, maintenance, storage and publishing of documents and document components that require regulatory submissions.
• Responsibility included writing the validation deliverables including Risk Assessment, Validation Plan, ST Summary, UAT Summary and VSR. Review of ST Plan, IQ/OQ Plan, and IQ/OQ Summary, IQ/OQ scripts, ST scripts, UAT scripts, TM, Deployment Plan, Training Plan and providing guidance on other validation related activities.

Sr. QA Lead

Confidential

Responsibilities:

• Worked on Electronic Laboratory Notebook (ELN) application by Cambridge Soft utilized by the R & D groups within BMS to capture experiment data from Chemistry, Biology and other integrated studies.
• The application facilitated experiment data utilizing LIMS for capture and storage.
• Utilized HPQC and JIRA tool for requirements, test scripts and defect tracking.

Sr. Validation Specialist

Confidential

Responsibilities:

• Worked on Siebel - OnBase system validation effort for a CRM application, which facilitated sales force automation group for generation of sample request forms.
• The application enabled business users in maintaining HCP data including state licenses, drug distribution and shipping information.
• The application integrated with content management system for safe handling and maintenance of current documents and also with sample shipping application to fulfill the drug and literature orders.
• Created validation deliverables for multiple releases of the application.

Validation Analyst

Confidential

Responsibilities:

• Worked as Lead Validation QA Analyst guiding the project team on the validation deliverables for an in-house developed application for analyzing and collaborating product data called Product Hub, which interfaces with ERP and other systems to collect Product Data. Wrote the Plans and Reports, reviewed validation deliverables and pre and post execution test scripts in HPQC.
• Guided the project team on good documentation and testing practices and break-fixes for Epic Star document control application. Reviewed application installation documents and other evidence to close changes in Remedy- Change Control.
• Participated in MS SharePoint qualification process. Provided validation/qualification route following company SOPs and processes to outside vendors.
• Wrote Plans and Reports for various other small projects including (Biological Assessment of Risk Global Repository, LIMS and Mobile Intelligence-Sales Force Automation System)
• Engaged in UAT process for ModelN (CMCB/GP) Revenue Management and Government Pricing System. The application interfaces with SAP and other systems calculating product pricing and evaluating government submissions and special pricing requirements and government reporting. The application facilitates the pricing and contract management groups to work collectively. Worked closely with the business team to plan and write UAT tests.
• Performed SAP/ModelN verification testing to ensure data integrity for critical transactions.

Validation Specialist

Confidential

Responsibilities:

• Validated IVRS and IWRS core systems for subject enrollment and randomization of subjects per study protocol stratifications and inclusion criteria.
• The application interfaces with the Drug Supply System and Web interface for reports.
• Created the entire suite of validation deliverables and interacted with the clinical teams to gather requirements and execution of protocols.

Validation Specialist/Change Control Coordinator

Confidential

Responsibilities:

• Worked for their Drug Safety Department validating “ARISg”, an adverse event reporting and monitoring system.
• Worked with the team testing a newly created component linking the application to the Confidential (Case Report Form) system that facilitated regulatory submissions. The component allowed the application to enhance the process to capture data directly from the country offices and agencies and entering the data into the AER system.
• Wrote documents including specifications, test scripts and reports. Responsibilities also included executing tests and summarizing test results for E2B electronic submissions to regulatory authorities.
• Coordinated change controls initiated as a result of updates and additions to the ARISg application system and MedDRA v8.1, 9.0, 9.1 (Medical Dictionary) upgrades for ARGUS 2.9.1 application.
• Created the documentation approval process for updates to system edit checks (Validations) for ARISg application.