PROFESSIONAL SUMMARY:

• Over 5 years of experience in pharmaceutical companies with specialization in areas of Computer System Validation (CSV).
• Working experience in FDA regulated environments and research laboratories with good understanding of cGxP (cGMP, cGDP, cGLP) standards.
• Familiarity with medical devices, with emphasis on FDA (21 CFR Part 11, 210, 211, 820), understanding and practical knowledge of GAMP 4 and GAMP 5 regulations
• Possess sound knowledge of Laboratory Information Management Systems (LIMS), SQL*LIMS, Scientific Data Management System (SDMS), Data Migration and Adverse Event Reporting System (AERS)
• Strong knowledge and experience in Software development Life Cycle and Validation Life Cycle development, familiarity with the WaterFall, Agile, Spiral and V Models.
• Experience in designing Test Plan, Test Scripts, Test Procedures, Test Cases, and developing validation protocols like Installation, Operational and Performance Qualification (IQ/OQ/PQ).
• Experience in reviewing, modifying and writing standard operating procedures (SOPs) and validation plans
• Highly experienced in Technical Writing, Documentation skills and Report Generation.
• Actively involved in document management process, workflow configuration and Project Management using Documentum, Trackwise, Pilgrim and Sharepoint.
• Extremely proficient in the maintenance, calibration and troubleshooting of equipment commonly used the biotechnology industry like centrifuges, incubators, mixers etc.
• Extensive laboratory research experience, highly comfortable with the implementation of cell culture techniques and gel characterization.
• Goal driven individual, with excellent written and oral communication skills, ability to work independently and as part of a multi - disciplinary team in a fast paced environment,
• Possess solid researching skills, analytical thinking, and problem solving skills.

PROFESSIONAL EXPERIENCE:

Confidential, Rockville, MD

Validation Analyst

Responsibilities:

• Involved in the calibration of HPLC and GC, and checked its accuracy, detection limits, noise level, precision, reproducibility, repeatability and robustness in order to maintain chromatographic data in compliance.
• Developed and executed IQ, OQ and PQ protocols for the computer system, prepared the VSR to summarize all the documentation and instrument validation activities.
• Created templates for method validation protocol, method validation report, standard test method.
• Gathered and signed off on URS and FRS for the Chemstation Software and its integration with LabWare LIMS.
• Prepared documents for Test cases for Integration, Functional Testing and User Acceptance Testing using Quality Center tool.
• Reviewed and drafted Standard Operating Procedures (SOPs) and User Manuals for the equipments and associated software to ensure they meet FDA requirements.
• Maintained Requirement Traceability Matrix (RTM) to track requirements.
• Assisted in initiating and conducting Gap Analysis and Remediation Plan for lab equipment and software interfaced with LIMS for 21 CFR Part 11 compliance and prepared Deviation Reports.
• Reviewed and carried out UAT, Positive testing, Negative testing, Regression testing for the Chemstation software.
• Also performed non-functional testing like Performance testing, Stress testing for the integration software using Winrunner
• Conducted unit testing of Labware LIMS software and involved in writing of Operational Qualification of various LIMS modules.
• Prepared specification documents for Labstation module of LIMS and created test scripts for positive, negative, regression and the validation of Labstation module for interfacing lab instruments with LIMS Lab Ware.

Confidential, East Hanover, NJ

Validation Specialist /Compliance Analyst

Responsibilities:

• Analyzed and documented Business Requirements and developed Master Test Plan
• Validated computer systems according to FDA regulations
• Developed and routed SOPs and Work Instructions, that were in accordance with GAMP regulations and also trained the required users
• Involved in developing and executing Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ) for GCS tool.
• Performed Risk Assessment and Risk Analysis and drafted remediation plans for Global Complaint System, to bring the system back into compliance
• Responsible for defining test Requirements, running manual scripts and scheduling automated tests for the various Trackwise modules add and tracking defects using Quality Center
• Configured the Trackwise workflow as per the specifications of the client software, and also configured data as per client convenience.
• Prepared UAT test cases and oversaw the execution of UAT test cases to business users
• Prepared Validation Summary Report (VSR), and documented and routed all the Validation deliverables using the EfileCabinet EDMS system.
• Created Requirement Traceability Matrix (RTM) to cross reference the functionality to the required test cases and scripts.
• Utilized the System Investigation Request to initiate the change control process.

Confidential, Deerfield, IL

Validation Analyst/Technical Writer

Responsibilities:

• Assessed the company’s current validation status preceding an internal audit, reviewed pre and post market summary reports to ensure compliance with FDA regulations.
• Was involved in validation of ARGUS Safety by creating a Validation Master Plan in accordance with FDA regulations, particularly 21 CFR Part 11, GLP and GMP.
• Involved in ensuring all compliant pre and post marketing safety reports, writing test specifications, testing methodologies and user manuals for Argus Safety.
• Generated and reviewed Computer System Validation (CSV) deliverables in compliance with 21CFR Part 11, GxP and FDA Compliance Regulations, including Validation Plan and Protocol, Installation Qualification (IQ) Specifications, Operation Qualification (OQ) Specifications, Performance Qualification Specification (PQ) Test Scripts, Test Cases and Vendor Assessment Report
• Contributed to the identification and implementation of process and system enhancements to improve Adverse Event dictionary maintenance and designing templates of reports for electronic report submission.
• Designed and wrote training manual templates, design formatting, project planning and proofing documents.
• Drafted SOPs for all the computerized systems to make them compliant with 21CFR Part 11 Rules and updated all the existing procedures, and trained users on these systems and the implications and impact of 21 CFR 11 compliant data systems on day-to-day functions
• Followed the Standard Operating Procedure SOPs of the company in documenting Test Plan, Test Cases and Test Procedure using Business requirements document and Functional requirements document of the system.
• Involved in updating the Testing Methodology for the QA department and generating various documents to provide uniformity in the execution and reporting of tests
• Drafted the Remediation Plan for systems that were partially compliant or non compliant with cGMP guidelines for Project Management approval after conducting Gap Analysis.
• Managed company’s Electronic Document management systems, ensuring classification of records and implementation of access controls of project workspaces, adhering to company’s Group Records Management policy.
• Delivered training as required, assuring that all project staff has a clear understanding of the document management policies.
• Served as the point of contact for document control function on day-to-day activities, assisted in the planning, development and implementation of the business’ overall document management program to include records management and drawing/document control.
• Maintained group access, folder hierarchy, folder defaults, metadata and performed audits of the EDMS to ensure compliance to approved procedures.
• Participated in technical team/network meetings for sharing best practices and setting priorities for future enhancements and system break/fix issues in EDMS.
• Assisted in the development and maintenance of business process workflows, supporting project team of document controllers.
• Developed and customized workflows, life cycles, jobs and methods using Documentum tools.
• Used Documentum Administrator to create the publishing configuration for publishing content to the website using WebCache .
• Provide support for EDMS users in the Regulatory and Clinical groups. Participated in vendor selection for next generation EDMS.
• Validated and implemented Documentum software upgrades across multiple development, test, and production environments