Validation Engineer Resume Frederick, MD - Hire IT People

SUMMARY

Over Six years of experience in Equipment Validation/ Computer SystemValidation/Quality Assurance in Pharmaceutical Industry with Extensive Knowledge on regulatory guidelines including 21 CFR Part 11, GAMP 5,ICH, EU and FDA.
Experienced in Predicate Regulations of FDA (21CFR Part 11/203/210/211/820 ), ICH, and EU regulated industry GAMP5, GMP, GCP, GLP.
Experienced with SOPs and best industry (GXP) practices.
Expertise in Computer System Validation (CSV) and Compliance with 21 CFR Part 11.
Thorough knowledge and awareness of the Software Development Life Cycle(SDLC) approach to computer systems development.
Responsible for authoring Validation Plan (VP) and Validation Summary Report (VSR).
Expertise on systems like Laboratory Information Management System(LIMS), Argus Safety, Document Management System(Documentum).
Expertise in using Documentum to handle document versions, workflows and lifecycles.
Experienced in authoring, reviewing and approving of Validation Protocols (IQ, OQ, PQ).
Experienced in preforming GAP Analysis, authoring Remediation Plan.
Experienced in Authoring, Reviewing and executingTest Scripts following Good Documentation Practices.
Experienced in documenting Requirements Traceability Matrix(RTM).
Experienced in performing Vendor Assessment.
Excellent knowledge of MS Word, Excel, Power point and Windows based applications.
Working knowledge on Manual and automated Testing tools like Quality center and QTP.
Hands on experience in leading various lab system projects concurrently through successful completion.
Excellent Pro - active, interpersonal, organizational, verbal and written communicationskills to handle enterprise environment.

PROFESSIONAL EXPERIENCE

Confidential, Frederick, MD

Validation Engineer

Responsibilities:

Responsible for authoring Validation Plan for Lab ware LIMS.
Experience in implementing the regulations according to GAMP 5
Responsible for implementing Risk Analysis approach.
Responsible for developing Standard Operating Procedures (SOPs).
Responsible for authoring, reviewing System and UAT Test Scripts.
Involved in executing System Test Scripts.
Coordinated with Business people in the execution of UAT.
Documented, reviewed and verified the results of the IQ, OQ and PQ protocol execution for LabWare LIMS.
Authored Validation Summary Reports (VSR) summarizing all the validation activities.
Maintained Test Error Reports(TERs) summarizing all the errors encountered during testing and provided resolutions accordingly.
Documented Traceability Matrix to track the Lab ware LIMS requirements and their corresponding Test Scripts.
Involved in archiving all the approved documentation.
Performed Vendor audit and documented the Vendor Evaluation Report.
Responsible for implementing 21 CFR part 11.

Confidential, Hauppauge, NY

Validation Analyst

Responsibilities:

Responsible for Validating Documentum following FDA guidelines.
Responsible for gathering requirements for Documentum from Business folks.
Documented User and Functional Requirements.
Involved in authoring OQ Test Plan.
Responsible for authoring OQ and UAT Test scripts.
Authored Test Scripts for Security and Audit Trial requirements.
Executed OQ Test Scripts.
Documented Requirements Traceability matrix(RTM).
Responsible for implementing work flows and lifecycles using Documentum.
Responsible in authoring migration and retirement plans.
Handled Quality Center for Test script execution and Load Runner for Performance Testing.
Maintained Electronic records and Electronic signatures as per 21 CFR part 11 guidelines.
Documented Deviation Reports.
Maintained Change Control Log of all change requests.
Authored Test Summary Report summarizing the test results and errors encountered.

Confidential, Deerfield, IL

Validation Consultant

Responsibilities:

Involved in validation activities of Adverse Event Reporting system by creating a Validation Master Plan and Validation Summary Report.
Reviewed and modified adequate procedures for the surveillance, receipt, evaluation, and reporting of Adverse Drug Experiences.
Responsible for performing Gap Analysis and developing Remediation Plan.
Involved in all aspects of the computer system validation lifecycle, to comply with FDA regulations (21 CFR Part 11) providing important information about the dynamic operation of the instrument and in satisfying compliance requirements with FDA.
Involved in authoring IQ, OQ and UAT Test scripts.
Coordinated with Technical lead in the execution of IQs.
Coordinated with Business people in the execution of UAT.
Involved in the execution of System Test Scripts.
Documented the Traceability Matrix to track the requirements.
Recorded the test results and logged the errors.
Involved in training the associated End Users.
Involved in investigated discrepancies between test cases and results and made suggestions for resolution.
Reviewed and approved validation deliverables created by onsite and offshore testing team.

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Validation Engineer Resume

Frederick, MD

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