Juned AshrafbhaiKhakhi

ac91hn@r.postjobfree.com

316-***-****

Sr. validation Engineer

Summary

* ***** ** ********** ** highly regulated environment (FDA Part 11, 820, GLP, GCP, GMP, and GAMP 5) centered on compliance and delivery of high-quality risk assessment, design, implementation, validation, and maintenance solutions.

Experience in providing guidance on validation and compliance assessments for SAP R/3, Documentum, Docubridge, Trackwise,Siebel and LIMS.

Good knowledge of Software Development Life Cycle (SDLC) with Waterfall and Agile models.

Experienced in the development and execution of Validation Master Plan (VMP), Requirement Specifications (URS/ FRS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Requirements Traceability Matrix (RTM) in validation deliverables. Comprehensive knowledge related to 21 CFR Part 11Electronic records, Electronic signatures and Audit trials.

Experience in authoring and reviewing Validation Master Plan (VMP), Business/User Requirement Specification (BRS/URS),Design Specifications (DS), Functional Requirement Specification (FRS), Requirements Traceability Matrix (RTM), and Validation Summary Reports (VSR).

Professional experience in validation practices with good understanding of GAMP 5, cGxP(cGMP, cGLP, cGDP and cGCP) standards, Corrective and Preventive Actions (CAPA) Investigation.

Performed Gap Analysis of the system in accordance of the GxP Regulations compliance.

Actively participated in the team to develop Change Control, Configuration Management, Performance Monitoring, Problem Reporting, System Use and Training. Actively involved in Manual and Automation Testing.

Extensively experienced in testing process and defect management using HP Quality Center/ALM.

Experience in documenting all phases of system life cycle as required by FDA regulations.

Proficient computer skills with use of Microsoft Word, Excel, Power Point, Access, Visio and MS project.

Experience in validating Laboratory Information Management System (LIMS), Electronic Document Management System (EDMS), Change Control Management System (CCMS), Data Migration and Adverse Event Reporting System (AERS), Trackwise Quality Control Management System (QCMS).

Efficient in implementing QA auditing and methodologies, Test Cases, Test Plans, Test Documentation and excellent technical skills.

Expert in writing SOPs, Work Instruction documentation for robust processes and methods in compliance with the company policies. Experience in working with vendors, customers and other cross functional team members and team leads.

Experienced working withSoftware Development Life Cycle (SDLC) and Software Validation Life Cycle (SVLC)and Agile methodologies and documenting validation deliverables.

Experienced in maintenance of Electronic Records and Signatures and their restricted access.

Ability to work in a multidisciplinary team and problem-solving skills.

Impressive Analytical, interpersonal and communication skills.

TECHNICAL SKILLS

Operating System

Windows XP/2007/2008/2010

Language

C, SQL, Visual basic, VB Scripting

RDMS

MS Access, Oracle 8i/9i/10g, SQL Server 2000

Tools

MS-Office, MS-Word, MS-Outlook, MS-PowerPoint. MS-Office 365, Outlook 2010,2013,2016, Documentum, WinRunner/Load Runner/Quick Test Pro Systems,SAS, SAP, CORAL, PAMS.

Bug Tracking and Reporting

Mercury Test Director, PVCS Tracker, Rational Requisite Pro, Clear Quest, SA, Documentum, TrackWise., SharePoint, HP ALM/Quality Center.

Regulations

21 CFR Part 11 (210/211, 820), GAMP, c(GLP, GDP, GMP, GCP), IQ/OQ/PQ, LIMS, AERS, Audit Trails.

Work Experience

Signify Health, TX Jan'18 - Till Date

Sr. Validation Engineer

Responsibilities:

Prepared and maintained the Validation Strategy Document (VSD), Standard operating procedure (SOPs) and Validation Summary Report.

Involved in preparing documentation for all aspects of the computer system validation lifecycle, in accordance with FDA regulations, particularly 21 CFR Part 11 including Installation Qualification (IQ) Specification, Operation Qualification (OQ) Specification, Performance Qualification(PQ) Specification.

Documented end to end validation process for TrackWise (CAPA) to ensure compliance with company policies and procedures.

Developed and executed test plans, test strategies, test scripts for validation testing along with the Test Summary Report using HP-ALM.

Developed specific SOPs for the operation of instruments and their data analysis in a network managed LIMS environment.

Reviewed the Test Plan for installation of the interface module and validation of LIMS software to ensure its compliance with FDA regulations.

Performed Computer System Validation (CSV) using cGxP guidelines.

Performed Requirements Traceability Matrix (RTM) to track requirements

Developed Master Test Plan to strategize the testing approach to test SAP R/3 modules to meet the requirements defined in FRS.

Reviewed and Approved Process Workflows and Definition documents, User Requirements (URS), and Functional Requirements (FRS) documents.

Developed the Validation Summary Report which summarizes the validation activities that were performed for the LIMS application.

Actively involved in CAPA implementation and respective Change Control Procedures.

Documentation/reviewing validation activities as per GDP for regulatory agency submission.

Regular interaction with designers, developers and system analysts.

Designed and implemented complete software validation and quality assurance programs like Standard Operating Procedures (SOPs); templates for validation related documentation such as validation protocols and plans, Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ).

Involved in analysing the System Problem Reports (SPR) and identified the errors occurred during the execution protocols such as the Operational.

Prepared and updated Test Cases and test scripts in HP ALM using Trace Matrix, tracking business requirements to test cases and vice versa.

Reviewed User Requirement Specifications (URS) and Functional Requirement Specifications (FRS).

Participated in core team meetings to get more information relating to current defects in the system and timelines for various deliverables.

NeoGenomics, Inc., Fort Myers, FL Apr'16 - Dec'17

Sr. Validation Engineer

Responsibilities:

Gathered requirements from business users/SMEs and translated into User Requirement Specifications.

Performed the GAP analysis and Remediation Plans for components that were not full and mostly compliant to the GxP regulations.

Developed the Validation Master Plan (VMP) for SAP R/3 implementations and SAP release cycles by following the corporate guidelines and implemented

Validated different workflows like Event/Deviations/Lab Event/CAPA /Change Controls in TrackWise.

Responsible for gathering and developing User Requirements Specification and Functional Requirements Specifications developed Traceability Matrix.

Assisted the Business Analyst to finalize the user requirements for the software.

Executed the test cases using Quality Center and documented results as part of IQs, OQs and PQs

Experienced in authoring User Requirements Specification (URS), Functional Specification (FS), GAP Analysis, Design Specification (DS), Test Plan, IOPQ Protocol (Test Cases), Requirement Traceability Matrix (RTM), Training Matrix and Summary Reports.

Performed Document Reviews to be compliant according to FDA guidelines and GAMP5.

Served as a point of contact between the Validation and Business teams to ensure the user and functional requirements drafted meet the requirements of the business process.

Developed GAP analysis, Remediation Plan, maintenance of hybrid systems, closed and open record systems.

Worked on the validation of HP ALM 11.52 before it was implemented in Baxter and replaced the active working system (HPQC v.10).

Drafted procedural Test Plans, validation Plans, Test Summary Reports, and validation Summary Reports reviewed by upper management.

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

Developed Test Summary Report (TSR) based on the execution of test scripts.

Conducted User Acceptance Testing (UAT) to check the various functionalities and to make sure that all the user requirements are met and documented UAT summary reports.

Developing and maintaining GAMP lifecycle documentation, including user requirement specifications, functional.

Scheduled training sessions, managed, controlled various training forms, training records in compliance with 21CFR Part 11.

Designed and developed test plans and protocols, test scenarios and test scripts.

Tracked defects if any and linked them to the concerned tests and followed up on its status from time to time

Gather requirements from Business, translate them to the Technical team, and serve as a liaison between business and Technical to help resolve Business issues and defects.

Worked on multiple projects simultaneously. Coordinated and participated in the weekly meetings to ensure the project is on schedule.

Bedford Laboratories, Bedford, OH Nov'14 - Mar'16

Validation Engineer/ Technical Writer

Responsibilities:

Worked with the business and the external teams to draft the equipment related Standard Operating Procedures (SOP) and Work instructions (WI)

Analyzed the Business requirements and assisted in preparing the Validation Master Plan

Drafted procedural Test Plans, validation Plans, Test Summary Reports, and validation Summary Reports reviewed by upper management.

Collected User Requirements (URS) by interacting with the users and developed Design Specification (DS) for conformance with 21 CFR Part 11 based on the requirements

Developing and maintaining GAMP lifecycle documentation, including user requirement specifications, functional.

Performed Document Reviews to be compliant according to FDA guidelines and GAMP5.

Involving in creation of system/regression & acceptance testing activities like creation of test setup, test plan, test data creation, environment setup etc,.

Drafted procedural Test Plans, validation Plans, Test Summary Reports, and validation Summary Reports reviewed by upper management.Analyzed User and Functional requirements to develop Test Plans, Test Cases and Test Scripts.

Performed GUI and Functional Testing of the LIMS screens using manual testing.

Tracked, Investigated and resolved Bugs and defects using HP ALM.

Used SDLC (System Development Life Cycle) methodologies like the RUP and the Waterfall.

Developed Requirements Traceability Matrix (RTM) to track requirements and to align the work process.

Involved in developing and implementing the test strategy and performed various analyses.

Developed FRS (Functional Requirement Specification) and DS (Design Specification) from the URS (User Requirement Specification).

Participated in updating the Requirement Traceability Matrix.

Involved in preparing the compliance report featuring the existing status of the cGLP, cGMP sensitive computerized systems.

Performed periodic evaluation of validated/qualified state of systems.

Provided proactive consultation, guidance and support on compliance and quality requirements to the support teams.

MedStar Health, Hyattsville, MD Oct'12 - Oct'14

Sr. Validation Engineer

Responsibilities:

Processed/documented various changes against regulated and non-regulated services within the change management system.

Reviewed pre and post market summary reports to ensure compliance with FDA regulations.

Performed Risk Analysis on various software for GXP or non- GXP impact and level of validation required as per the company’s risk analysis procedures.

Reviewed and drafted Validation Master Plan document to outline the testing strategies implemented.

Documented and reviewed the execution of Installation Qualification Protocol (IQP), Installation\Configuration Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) protocols, Performance Monitoring Plan/ Protocol.

Involved in developing detailed Test Plan, Test Cases and Test Scripts using HP ALM for Functional, and Regression

Designed and developed the Requirements Traceability Matrix (RTM) to trace requirements.

Validated all phases of system life cycle as required by FDA regulations under 21 CFR Part 11 (Electronic Records and Electronic Signatures).

Calibration of HPLC detectors and gradient pumps as needed, work with a committee to re-write the Unit Guidelines and Record Checking SOP's, method transfers

Well versed with FDA regulations and working knowledge of cGMPs and documentation requirements including 21CFR 11, 210, and 211.

Responsible for operating and cleaning procedures (SOPs) for manufacturing equipment.

Conducted regular audits to ensure for cGMP and cGLP compliance

Worked in a strictly regulatedcGXP environment for all the aspects Equipment Validation.

Developed validation testing deliverables, User Requirements, Functional Specifications, Installation Qualification, Operational Qualifications, Cleaning Validation Qualification, and Process Qualification protocols.

Wrote Working Instructions for different users of the application and assisted in drafting the Standard Operating Procedures (SOP).

Experience in documenting User Requirements Specifications (URS), Functional Specifications (FS) and Design Specifications (DS) documents.

Excellent understanding of Software Development Life Cycle (SDLC).

Responsible for developing the Data Migration Plan and Data Migration Verification Report

Created Validation plan based on the initial analysis of system requirements

Worked on MS Project, to update the timelines and to schedule the project deliverables in a timely manner.

Mylan Laboratories, India Aug'11 - Sep'12

Validation Analyst

Responsibilities:

Authored and Reviewed Business requirement and Functional requirement document.

Involved in collection of User Requirements, Functional Requirements and generating Conformance Standard Documents.

Developed UAT scripts for the system testing and performed dry run to find out the issues in system before the final UAT execution.

Involved in the upgrading of validation Master Plan.

Involved in performing GAP analysis of the current system and authored Remediation Plan for potential risks and failures for process and equipment’s.

Developed and maintained Requirement Traceability Matrix (RTM).

Managed bug-tracking cycle with daily release calls with developers and various members of team to discuss and resolve defects arose during the UAT (User Acceptance Testing) execution.

Execute a variety of validation protocols, Summary Reports and Change Control forms for manufacturing equipment, utilities, process, lab, etc.

Updated and maintained laboratory investigation and deviations Excel spreadsheets

Reviewed User Requirement Specifications (URS), Detailed Design Specification (DDS), Functional Specification (FS) and Process Specifications.

Performed GAP analysis to ensure compliance with GxP.

Developed Remediation Plan to bring the system in compliance with GxP.

Prepared Validation Summary Reports (VSR).

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