Summary

• Over 7 years of experience in Pharmaceutical, Biotech, Drug and Device Manufacturing Industry with Software Development Life Cycle, 21 CFR Part-11 Validation, Change Control Management testing and implementation of business applications.
• Reviewed and Validated Computer Systems in compliance with 21 CFR Part 11 and GxP FDA Regulations and QSR 820
• Abundant experience in generating and reviewing Computer Systems Validations CSV Deliverables according to 21 CFR Part 11 and FDA regulations for the Pharmaceutical industries
• Working knowledge of GLP, GCP, GMP, GAMP V guidelines especially in the areas of computer or related systems
• Experience in preparation and review of Validation Protocols IQ/OQ/PQ documentation, VP, VSR, SOPs, Protocol Deviation, Risk Assessment, Decommission report, Periodic Review Report.
• Experience in reviewing all SDLC documents, protocols and SOP's to ensure they meet GxP and FDA regulations
• Experience in Developing and reviewing User Requirement Specifications URS , Functional Requirements Specification FRS and Requirement Traceability Matrix RTM Documents
• Good experience in Gap Analysis and documenting Remediation Plan
• Excellent Knowledge and experience in Good Documentation Practices
• Demonstrated capability to quickly gain a detailed understanding of a process in order to optimize efficiencies and improve quality.
• Well versed in phases of clinical trials and GCP as of 21 CFR 50 and 56.
• Excellent experience in applying FDA regulations to the aspects of the Computer and Lab Systems.

Skills

Databases : SQL 2008, Oracle 10.x

Operating Systems : Windows 7, XP, and 2000

Others :MS Excel, MS Office, MS Power Point, MS Share Point, Visio, SAP front end, eDOCs, LMS

Industry Regulations : 21 CFR Part 11, GxP GMP, GCP, GLP , CFR Part 211, Annex 11

Scientific Skills : Protein and Enzyme Assays, Tissue Culture

Testing : Test protocol design, SDLC, Requirements Analysis, Test Plan

: Development and Implementation, User Acceptance Testing,

Regression Testing, System Testing, and Integration Testing using HPQC 10.0.

Confidential

Computer Systems Validation Specialist

Applications Security Weaver for password re-set, SAP front end for routing for approval and maintaining document, and eDOCs to maintain document and Computerized laboratory systems Shimadzu TOC, UV , Agilent 1200 HPLC, Water Empower Software, Endoscan-v KTA, Micro PRO microbial count, GeneAmp PCR, Spreadsheet calculator, LIMS, Argus pharmacovigilanceand Metrohm AG 940 autotitrator are used in lab for research on infectious diseases and development of vaccines by the Microbiology Department. Anthrax vaccine manufacturing site.

Responsibilities

• Followed Computer Systems Validation CSV Master Plan to author, review and approve CSV deliverables for systems as per GxP GLP, GCP, GMP, GDP, cGMP FDA Assessment.
• Authored, reviewed and approved CSV deliverables Validation Project Plan, URS, TM, IQ, PQ, UAT, Vendor Postal Audit Report, Computer System Risk Assessment, Periodic Review Report, Decommission Report, and Validation Summary Report for TempTale Desktop Manager used by the Supply Chain.
• Routed computerized systems documents Validation Project Plan, URS, TM, IQ, PQ, UAT, Vendor Postal Audit Report, Computer System Risk Assessment, Periodic Review Report, Decommission Report, SOPs, and Validation Summary Report using SAP and eDOCs for review and approval.
• Co-ordinated with the vendors in commissioning of the instruments upgrade software, implement new system or maintenance of systems , system suitability tests, and resolving technical issues
• Assessed risk related to the systems and analyze them, if necessary with the Team.
• Directly work with QA for implementing new and upgrading previously validated systems.
• Validated systems used for GMP and Non-GMP purpose.
• Reviewed and followed SOPs to help the business process in line with FDA regulations.
• Organized and attended meeting to discuss the status of the projects.

Confidential

Senior Validation Analyst

Application is used for archiving experimental and genomic imaging sets consisting of Confidential 3400 high-resolution digital camera and computer acquisition system and integrated with Perkin Elmer microscope, and Agilent Confidential series. Used for research of diseases such as cancer, and atherosclerosis.

Responsibilities

• Followed Computer System Validation CSV Master Plan to prepare, review and approve Validation deliverables for both CSV IT and Laboratory systems as per GxP GLP, GCP, GMP, c GMP FDA Assessment.
• Developed, reviewed and approved CSV deliverables for Bioanalyzer.
• Developed URS for microscope.
• Co-ordinated with the vendors in commissioning of the instruments, vendor audit, system and suitability tests.
• Developed, reviewed and approved vendor postal audit and vendor risk assessment report.
• Involved in risk analysis of the requirements with the Team.
• Developed and executed IQ, OQ and PQ protocols.
• Co-ordinated with IT to maintained server qualifications both application and the database servers.
• Revalidated SOPs to help the business process in line as per FDA regulations
• Verified Audit Trails, logical security and user privileges.

Confidential

Sr. Validation consultant

Responsibilities:

• Involved in developing, and reviewing Computer System Validation deliverables in compliance with FDA 21CFR Part11, CFR Part 210 and GxP GLP, GCP, GMP Compliance Regulations
• Authored, and approved validation protocols for different computerize laboratory system as per 21 CFR part 11 compliance.
• Reviewed and approved the Functional Requirement Specifications
• Followed SOPs for data backup procedures
• Developed and executed the IQ, OQ, PQ for Waters Empower Software, CDMS CTMS applications
• Reviewed Requirements Trace ability Matrix RTM .
• Authored and Approved Validation Summary Report document.
• Created and provided computer validation training programs to ensure Regulatory Compliance
• Followed the risk analysis process, assessment process, and change control procedures for Computerized Laboratory System as per company rules and regulation
• Responsible for documenting Test Plans that contains Test Scripts, Test Cases, test data and expected results for user-acceptance testing
• Good experience in Unit, Integration, Functional, Validation, System and Regression Testing.
• Used HPQC Quality Center for the testing and also for tracking and reporting test defects.

Confidential

Validation Analyst

Project involved validation of in house developed Sample Manager for Allergan Labs. The system was validated to meet the GLP and 21 CFR part 11 Compliance.

Responsibilities:

• Developed User and Functional requirements for the application and documented the required changes as per Computer System Validation Master Plan.
• Reviewed the user requirement document.
• Created the Validation Test Plan and Test Criteria.
• Wrote the Validation Risk Assessment for the system to understand the importance of validation.
• Developed the process flow in consultation with the business and process teams.
• Involved in deviation investigations, SOP preparation and quality system development, documentation control, and equipment qualification.
• Completed a flowchart for Sample Manager and Labware LIMS to demonstrate appropriate workflow functionality.
• Co-coordinated with Systems owner and Business analyst to setup Pre-Validation and Validation environment to execute the scripts.
• Involved in preparing compliance report including 21 CFR Part 11 functionalities with the existing status of the cGMP sensitive computerized systems.
• Used HPQC Quality Center for the testing and also for tracking and reporting test defects.

Confidential

Responsibilities:

• Involved in Validation of Lab Instruments TOC, UV Spectrophotometer, and HPLC Shimadzu Series
• Involved with System Risk Analysis
• Prepared and reviewed Validation deliverables, periodic review report, Test cases Validation Reports
• Developed SOPs, Protocols and Project Plans.
• Involved in the implementation of regular data collection, analysis and validation using MS-Access and MS Excel
• Developed and executed User Acceptance Protocol Test Plan, test strategy, detailed test Subjects to describe the specific objectives, procedures, data sets, test scenarios, expected results, and acceptance criteria for the User Acceptance Testing UAT process
• Validated the processes reviewed qualification documents IQ, OQ and PQ
• Worked on Track wise
• Maintained validation package based on the requirements to meet the GxP GLP, GMP, GDP , and FDA 21 CFR Part 211 compliance.

Confidential

Validation Consultant

Confidential pharmaceuticals leading product, Confidential is targeted as a treatment for people with diabetes who use Insulin. The project is the implementation Confidential Web, an enterprise solution from Argus/Relays. It enables customer representatives to enter product complaint information on-line in real-time, while on the phone with the customer. It supports trending analysis primarily used by the QA department and the summarize findings for regulatory reporting and history file.

Responsibilities:

• Verified, clarified and signed-off of the functional requirements/functional specification.
• Involved in a team to prepare software validation protocols for interfaces between Argus and other systems such as QCIS Quality Information Systems and custom made internal spreadsheet legacy applications.
• Developed and reviewed validation plans, Validation reports, and Traceability Matrix.
• Prepared and executed IQ, OQ documentation.
• Played a key role on project issues such as release management, change management, scope control, and requirements prioritization.
• Developed SOPs and compiled Training Manuals for the new working environment.
• Documented strategy for maintaining the Validated State.
• Worked extensively with the QA team for designing Test Plan and develop the Test Scripts for the User Acceptance Testing.
• Utilized Win Runner and HP quality center to automate the regression testing process.
• Addressed GxP GLP, GCP, GMP FDA's CFR part 211, CFR Part 210 approach to compliance issues, and summarized the outstanding problems and issues.
• Communicated the daily operations of the validation team to the management and assured that the master plans, protocols and reports are generated, reviewed and approved within predetermined time lines.

Confidential

Product Executive Responsibilities:

• Managed and maintained products stock according to guidelines.
• Review of promotional materials as per the Label specifications compliance with GxP GLP, GCP, GMP, and GDP FDA Compliance Regulations.
• Used PDM/PLM tools to store data files.
• Updating of distribution list for all the Parma products in the database.
• Worked as a team lead, coordinated meeting and developed summary report.
• Involved in the training of personnel in PDMA rules in co-ordination with the regulatory team.
• Managed the customer complaints pertaining to the products in the region.

Poster Presentation:

• 1.A. Confidential Shugrue1, T. R. Kolodecik1, and E. Thrower1. Effects of cigarette toxins and alcohol in pancreatitis. 1Section of Digestive Diseases, Veterans Administration Connecticut Healthcare, West Haven, 1University of New Haven, West Haven, CT 2Yale University School of Medicine, New Haven, CT.
• 2.C. Shugrue1, E. Akinbiyi1, M. Shitia1, V. Patel1, T. R. Kolodecik1, N. Tashkandi1, B. Sreekumar1, A. Chowdhury1, E. Thrower1, and F.S. Gorelick1, 2. AMPK Activators Salicylate and Metformine Reduce Pancreatitis Responses in an in vivo Cerulein Model of Acute Pancreatitis. 1Department of Internal Medicine, Section of Digestive Diseases, 2Department of Cell Biology, Yale University School of Medicine, New Haven, and VA Connecticut Healthcare, West Haven Connecticut.
• Abstract:
• 1M. Ashat1, N. Tashkandi1, B. Sreekumar1, V. Patel1, A. Chowdhury1, C. Shugrue1, S. Messenger2, G. Groblewski2, E. Thrower1. TOBACCO TOXIN NNK 4- METHYLNITROSAMINO -1- 3-PYRIDYL -1-BUTANONE MEDIATES ZYMOGEN ACTIVATION IN MURINE AND HUMAN PANCREATIC ACINI. DDW. 1Section of Digestive Diseases, VA Connecticut Healthcare, West Haven, Yale University School of Medicine, New Haven, Connecticut 06520, U.S.A. 2Department of Nutritional Sciences, University of Wisconsin Madison, WI 53706.