SUMMARY:

• IT Professional with over seven (7) years of experience focused on Quality Systems and Computer System Validation (CSV) and with strict adherence to GAMP & cGMP regulations in the Pharmaceutical industry.
• Experience in GxPs, and 21 - CFR Part 11 regulations of Electronic Records, Electronic Signatures and Audit Trails for IT Applications.
• Responsible in reviewing of NCs and CAPAs. Worked on NC investigations including Root Cause Analysis and implementation of Corrective action and Preventive Actions (CAPA).
• Proficient in dealing with NC/CAPA System, Service Now (IRIS), Laboratory Information Management System (LIMS), Electronic Document Management System (EDMS) and Adverse Events Reporting System (AERS)
• Experience in reviewing Testing documentation - Test Procedures, Test Plans, Test Scripts and Test Summary Reports for applications.
• Hands-On HP ALM for the testing practices in test execution and followed Good Testing Practices.
• Experience in Software Development Life Cycle (SDLC), familiar with Waterfall, V-shape model and agile model.
• Updated weekly-status reports on the NC and CAPA updates and ensured on-track.
• Attended and responsible for taking meeting minutes for the daily NC/CAPA review meetings.
• Hands-On EDMS application for the IQ/OQ template document reviews and also to ensure about the effectiveness of the SOP and IQ/OQ documents.
• Extensively used Documentum for storage and retrieval of documents.
• Experience in reviewing User Requirements and Functional Requirements in compliance and conformance with FDA regulations.
• Knowledge on Risk Assessment, Remediation Plan, Deviation report, and User Acceptance Testing (UAT).
• Involved in analyzing the User Acceptance Test Summary Report.

TECHNICAL SKILLS:

Analytical Software: Lab ware LIMS, Sample Manager LIMS 11.2, Change Control CCMS, Argus AERS, Electronic Document Management System EDMS

Testing Tools: HP ALM 11.0/12.01/12.50/12.51

MS Office: MS Project, MS Visio, MS Office (Word, Excel, PowerPoint)

Compliance: FDA Quality system regulations, 21 CFR Part 11, GxPs

Tools: Service Now (Change Management)Track wise 8 (CAPA Management & Audit Management)Doc Compliance (EDMS), Compliance Wire (Learning Management System)

Methodologies: SDLC - Waterfall, V-model, SDLC & Project Coordination- Agile

PROFESSIONAL EXPERIENCE:

Confidential, Raritan, NJ

Quality Systems Specialist

Responsibilities:

• Responsible in handling NCs and CAPA activities for Application Services related GxP issues.
• Handled over hundred Document Uploads, fifty quality document reviews and completed them on-time
• Dealt with over forty NCs and ensured there is no over-due and succeeded in following up with multiple action items
• Assisted AS Team in SOP expedites and uploads although they are not related to the on-going project.
• Actively scheduled follow up meetings with NC/CAPA/Audit observation owners to help complete investigation and followed up on action items.
• Stayed on top of all action items and their schedule and closed NCs/CAPAs/Audit observations on time.
• Drafted and proof read nonconformance and CAPA records and subsequent quality documents to be filed with non-conformances, CAPAs, and audit remediation records in ServiceNow.
• Reviewed daily Reliability reports and managed meetings with reliability owners and meeting outcome/action items for Application Services.
• Assisted EDMS team in testing MyQumas Application using HP ALM.
• Executed and reviewed validation test scripts for MyQumas Application using HP ALM
• Executed the test cases stored in the Test Plan by importing locally to the Test Lab module in HP ALM and reported the defects.
• Provided Document Management process support for ITS business partners, such as uploading quality system documents to the document management system (EDMS).
• Supported EDMS document review and training related activities to expedite SOP updates and training assignments.
• Drafted and facilitated release of playbooks, quality system documents, and other types of documents required to support NC/CAPA, Audit, and ITS Application Services support activities.
• Helped manager to complete nonconformance and CAPA records in ServiceNow.
• Facilitated and managed meetings with cross-functional teams.
• Followed up on NC/CAPA/Audit remediation activities for on-time closure in a proactive manner.
• Listed out tasks on a weekly basis for follow up on his/her own based on priority and due date.
• Responsible in Assisting the Gap Assessments on the SOPs.
• Submitted user requests for EDMS viewer roles and EDMS QSD Author roles.
• Submitted Access Requests for NC and CAPA Owners required for access to NCs/CAPAs.
• Submitted Service Requests for trainings to SOPs and for the early release of the WI and SOP documents.
• Worked on the Contact Us functionality for about 500 J&J websites (both Products and Legal Manufacturing sites) required for the CAPA Effectiveness Check.

Confidential, Lake County, IL

Validation Tester

Responsibilities:

• Support in validation efforts and deliverables for project requiring validation.
• Executed validation test scripts and documented test results in accordance with standards.
• Revised Validation Policy and SOP's as directed.
• Responsible for testing QC Upgrade on HP ALM 12.50
• Attended the Kick-off meetings and successfully accomplished the tasks according to Plan of Action.
• Assisted our Project Manager in some Compliance work related projects using SharePoint and MS-Excel.
• Involved in Dry Runs and QA Executions of the protocols for SampleManager LIMS.
• Responsible for generating ER Reports and Effectiveness Check for CAPA.
• Involved in assisting CAPA Process and generating the reports necessary using Trackwise.
• Updated Comment Logs in SharePoint after the Peer Review of SQA.
• Responsible for updating test scripts in test plan and for execution in test lab modules of Quality Center 11.0.
• Assisted in documenting tasks such as Corrections, Corrective Action & Preventive Actions (CAPA) as applicable in the Trackwise application.
• Reviewing Corrective and Preventive Actions (CAPA) and highlighting and suggesting the remediation plans to mitigate the non-compliance.
• Reviewed authorized test scripts by the testers and approved them.
• Reported the defects in the execution of the test scripts to the developers using Defect Tracking Tools like Quality Center and updated bug report status
• Quality review of all documentations in aspect of the Computer System Validation Lifecycle.
• Attended the trainings for HP ALM 12.51 Application Upgrade.

Confidential, Deerfield, IL

Quality Systems Specialist/Validation Lead

Responsibilities:

• Hands on ServiceNow for Change Control/Change Management, Problem Management, Incident Management and Approval Management of Applications.
• Reviewing Corrective Action and Preventive Action (CAPA) and drafting Remediation plans for the project management approval after GAP analysis.
• Collaborated with the Quality Team and Validation Team to setup a Change Request process for the project.
• Responsible to address the causes of nonconformity in case of occurrence of issues related to Patient Safety/Health, Regulatory Compliance and GxP-regulated activities.
• Responsible for creating the Corrective and Preventive Action Plan (CAPA). Accountable for ensuring that the activities described for the process of Exception report initiation and Corrective Action and Preventive Action (CAPA) are implemented and documented in case of occurrence of a nonconforming event or issue.
• Responsible for managing an Exception Report to timely completion.
• Involved in tracking and determining trend of events when investigation is required.
• Identification of all of the impacted and potentially impacted items (bracketing) and interim controls.
• Responsible for evaluating and assigning the Impact Assessment Rating considering the Severity, Frequency and Detectability of the issue.
• Generated and documented tasks such as Corrections, Corrective Action & Preventive Actions (CAPA) including Effectiveness Checks (EC) as applicable in the TrackWise module for Exceptions.
• Reviewed documents (Project Plan, Test Plan, Test Cases) as part of Quality review.
• Reported the defects in the execution of the test scripts to the developers using Defect Tracking Tools like HP ALM and updated bug report status
• Participated in conference calls with the Business as well as Development participants for discussing results, decision-making and planning of the testing processes.
• Worked on MS Project, to update the timelines and to schedule the project deliverables in a timely manner.
• Initiated the GAP analysis to identify the changes to be included in the current upgrade functionalities from the Control Change Request (CCR) log.

Confidential

Validation Analyst

Responsibilities:

• Worked on change control documentation such as Change Request Form (CRF’s), Change Control Implementation Plan, Change Control Summary Report.
• Attended change request meetings to document changes and implemented procedures to test changes.
• Responsible for reviewing change control SOP’s to comply with 21 CFR Part 11 requirements.
• Performed change control by assessing proposed changes to validated processes and identify the validation requirements necessary to maintain the validation status after execution of the change.
• Responsible for creating the Corrective and Preventive Action Plan (CAPA)
• Validated the Change Control Forms for QA and ensured the overall risks of all the transports met the Business Criticality.
• Performed quality review and approval of documents supporting computer system validation processes.
• Responsible for reviewing Work Instructions for Change control.
• Revised Standard Operating Procedures (SOPs) to govern the development, change management, testing, release, deployment, training, document control in Software Development Life Cycle (SDLC).
• Reviewed and modified existing Standard Operating Procedures (SOPs) for Change Control Procedures.
• Traced RTM (Requirement Traceability Matrix) to identify affected system components when there is a required change.
• Initiated Good Documentation Practice guidelines and workflow diagrams for performing Change Control Management.
• Reviewed Requirement Traceability Matrix (RTM) to track requirements during the QA Testing Phase.

Confidential, Middlesex, NJ

Software Tester

Responsibilities:

• Followed the Standard Operating Procedure for Document management system.
• Maintained all the logs and documents through a document management system, Documentum
• Utilized Documentum for storage and retrieval of documents.
• Involved in reviewing the Risk Assessment documents, Test Summary Documents and Validation Summary Report (VSR) to summarize overall validation activities and to establish documented evidence that the system was validated according to the standards of 21 CFR Part 11.
• Responsible for executing Functional and Regression Testing.
• Worked closely with the Business Analyst to understand the business process.
• Involved in Performance Testing to improve user experience.
• Reviewed test plans, test strategies, test scripts for validation testing along with the Test Summary Report.
• Responsible for reviewing Validation Summary Report and involved in Efficiency Testing.
• Worked with Requirement Traceability Matrix (RTM) to track requirements to co-relate with the conducted test cases.
• Reviewed test cases and scripts as per the company Standards.
• Hands-On Argus system modules such as patient-monitoring system and case reporting.

Confidential

Validation Tester Trainee

Responsibilities:

• Responsible for validating the reports generated by the application are in compliance with 21 CFR part 11 and cGMP requirements.
• Reviewed the previous documentation for each module in the Labware LIMS application, and upgraded to the current template formats.
• Reviewed User and Functional requirements on individual modules of LIMS.
• Participated in Performance testing.
• Responsible for Reporting and managing defects to ensure that all issues are resolved according to established guidelines and expectations.
• Worked with Audits and performed quality check to verify the performance quality of the services.
• Met clients and collected information required in order to set the minimum standards of the URS documents
• Maintained and controlled Electronic Records, Digital Signatures, Electronic Signatures and capturing Audit Trails with respect to 21CFR Part 11 requirements.
• Performed Load testing to determine a system’s behavior in different conditions.