- Extensive experience as Validation Specialist/ Quality Engineer in the pharmaceutical and medical device industry with comprehensive understanding of systems testing and technical documentation.
- Expertise in preparing all required documents for Computer System Validation (CSV) lifecycle, including Validation Master Plan (VMP), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Validation Summary Report (VSR).
- Expertise in FDA regulated environment with good understanding of cGxP (cGMP, cGDP, cGLP) standards, 21 CFR Part 11, 210, 211, 820 and ISO 13485 risk based validation.
- Investigated the deviations through CAPA, recommended the necessary changes.
- Experience in Corrective Action Prevention Action (CAPA), Change Control Process, Training, Investigations and Document Management Process.
- Well acquainted with every phase of Software Development Life Cycle (SDLC) and Validation Life Cycle (VLC).
- Adept with automated tools such as WinRunner, Quick Test Professional (QTP), Test Director and Mercury Quality Center (MQC), Rational requisite pro.
- Proficient in maintaining and working with advanced software engineering tools such as LIMS - (Laboratory Information Management Systems) and AERS (Adverse Event Reporting Systems).
- Expert knowledge in conducting manual and automated testing such as Functionality, Regression, Positive testing, Negative testing, System testing, and Performance testing.
- Motivated individual exhibiting team spirit qualities with excellent communication and interpersonal skills.
- Proficient in data entry using drug safety databases ( ARGUS, ARISg ).
- Collecting, documenting, and processing of adverse event reports from clinical trials and post - marketing sources .
- Reconciliation of SAEs between drug safety and clinical trial database .
Confidential, Levittown, PA
- Validated analytical laboratory equipments such as GC, HPLC and Spectrophotometers in compliance with FDA regulations
- Acquired and documented the business requirements
- Prepared Validation Master Plan ( VMP) for validating analytical laboratory equipments and LIMS.
- Generated Validation Summary Report to summarize and document all validation activities
- Developed and reviewed Standard Operating Procedures ( SOPs) for various functionalities of the system
- Reviewed the Test Strategy document prepared by the testing team and provided input on the validation requirements.
- Involved in creation, execution and responsible for pre and post execution review of Unit Test scripts, Performance / Automated Test Scripts, Regression Test Scripts, IQ / OQ / PQ Test Scripts and UAT Test Scripts .
- Imported URS and FRS requirements to Quality Center for traceability.
- Analyzed test scripts to check whether all functionalities have been covered within the compliance of 21 CFR Part 11
- Responsible for ensuring the compliance of GMP / GLP and FDA regulations
Confidential, Shawnee, KS
- Prepared documentation for all aspects of the Computer System Validation (CSV) lifecycle, in accordance with FDA regulations including 21 CFR Part 11.
- Involved in developing Test Plans and Summary Reports for TrackWise system implementation.
- Performed Computer System Validation Assessment for Labware LIMS system to identify the validation deliverables for the project implementation.
- Analyzed System Requirements to document in Function Requirements Specification (FRS) and Design Specifications (DS).
- Developed Master Test Plan for LIMS implementation and its interface to SAP R/3 via WebMethids, to define the test strategy and test cycles.
- Developed Application Installation Qualification (IQ) to install the application and Functional Test Protocol (OQ) as a part of testing.
- Tracked all deviations and corrective actions as part of the test process.
- Implemented Good Documentation Practices (GDP) to review and approve the Test Scripts pre-execution and post approval.
- Developed Test Summary Report to summarize all test activities done in controlled test environment.
- Conducted Risk Analysis meetings to analyze the risk involved in implementing the TrackWise system in the existing business process.
- Prepared Traceability Matrix to define the relationship between Requirements, Design Specifications and Test Scripts
- Developed the final Validation Summary Report and Go-Live memo to issue the LIMS system into production use.
Confidential, Lake County, IL
- Worked with Validation Manager in defining the boundaries of validation activities in Planning.
- Created and Reviewed Operation Qualifications (OQ) and User Acceptance Testing (UAT) test cases for different modules of LIMS based on the User and Functional Requirement specifications (UFRS).
- Developed, reviewed and executed the system related IQ /OQ and PQ.
- Validated Login screens and access profiles in LIMS based on the user requirements for User Interface (UI) testing.
- Reviewed, coordinated and maintained CSV Change Controls. Prepared Periodic Reports for outstanding Change Controls.
- Drafted new SOP’s and trained all users on the systems, implications and impact of 21 CFR Part 11 compliant data systems on day-to-day functions.
- Wrote and executed test scripts based on the test plan and in accordance with Good Documentation Practices (GDP).
- Performed System Integration Testing to verify that the integration of different LIMS modules has been successful and reporting interface errors.
- Performed Functionality, GUI and Regression testing using Winrunner.
- Performed backend testing by executing SQL commands using SQL*Plus.
- Reported Variances using Defect tracking tool and re-executed upon resolution using Test Director.
- Documented test execution report and prepared Requirement Traceability Matrix (RTM).
- Performed Gap Analysis of the system taking into account the User Requirements and System Requirements. Also developed a Remediation Plan for various compliance issues like Change Control.
- Involved in auditing the application for 21 CFR Part 11 compliance related to Electronic Signatures and Electronic Records for a closed System.
- Maintain Change control and qualification records.
Confidential, Spring Valley, NY
- Created and maintained the project plans. Presented the project plan and associated project schedule to the project team for review and input.
- Prepared documentation for all the aspects of Validation in accordance with 21 CFR Part 11 regulations.
- Ensured the adherence to PAR SDLC and application development policies and procedures.
- Coordinated with the ELN Development team and Infrastructure team to facilitate discussions around the technical aspects of the system, as defined by the project plan.
- Administered updates to the User Requirement Specifications.
- Responsible for design and construction of the delivered system to fully meet the defined user requirements.
- Responsible for Validation Plan development, review, approval, and maintenance.
- Administered changes required to the validation deliverables for the system.
- Supported the assembly of the Functional and Design Requirements Specification documents.
- Owned and oversee the development of validation documentation.
- Responsible for project management activities related to testing.
- Prepared the Validation Protocol development, review, and approval.
- Testing documentation development, review, pre-approval, execution, and post-approval of IQ, OQ, and PQ.
- Prepared the Summary Report development, review, and approval.
- Acted as primary member with ELN Team representatives and Subject Matter Experts to develop system requirements.
- Coordinated with Infrastructure Team to develop HW / SW design for system implementation.
- Assisted Business Analyst in the assessment and gathering of supporting documentation, such as Test Method SOPs, Material Specifications, Test Data Sheets, Reports etc.
- Assisted Development Team with configuration of the Formulator ELN product.
- Facilitated Change Control processes related to application or system updates made to the production system.
- Developed system-specific Standard Operating Procedures (SOPs) for the utilization of the ELN.