Engineer Testing

Sandhya

*******.***@*****.***

Professional Summary:

Over 7 years of experience in Technical Writing, Computer System Validation

and Quality Assurance.

Strong understanding of 21 CFR Part 11 drug cGxP requirements including

electronic records, electronic signatures, system validation strategies and

documentation.

In depth knowledge of GxP(GMP, GLP and GCP)

Implemented TrackWise as a complete end to end solution to address the

implementation of Product Complaints Handling, Investigation, (Food and

Drug Administration) reporting, Risk Assessment, Trending and CAPA

(Corrective & Preventive Action).

Good experience in Software Development Life Cycle (SDLC), familiar with

Waterfall, V-shape and Agile models

Expertise in preparing and reviewing User Requirement Specifications

(URS), Functional Requirement Specifications (FRS) and Design

Specifications (DS) in compliance and conformance with FDA rules and

regulations.

Comprehensive knowledge and extensive experience in preparing and

reviewing Test Plans, Validation protocols (Installation Qualification -

IQ, Operational Qualification - OQ and Performance Qualification - PQ),

Test Summary Report and Requirement Traceability Matrix (RTM).

Proficient in developing Test Scripts, Test Cases, Test Plans, Test

Procedures, Test requirements and testing standards

Good experience of performing Gap analysis and preparing Remediation Plan.

Good experience in writing Risk Assessment, Deviation report, Discrepancy

report

Experience in handling Analytical instruments like the HPLC, GC, GC-MS, LC-

MS,ICP-MS and use of this knowledge in LIMS application

Skilled in developing Standard Operating Procedures (SOP's), policies and

working instructions to comply with FDA regulations.

Experience with Laboratory Information Management System (LIMS), Adverse

Events Reporting Systems (AERS), Change Control Management System and

Enterprise Document Management System (EDMS).

Aptitude in System testing performed manual testing and automated testing.

Proficient with Excel to manage different testing and data segregation

activities.

Good Knowledge of MS-Project, HP Quality Center, MS Visio and Documentum.

Good understanding of Sarbanes Oxley Regulation (SOX), Sunshine act,

Information Technology Infrastructure Library (IT-IL) guidelines.

Excellent communication, writing and interpersonal skills and strong

ability to perform as part individually and also as a part of team.

TECHNICAL SKILLS:

Computer System Validation: 21 CFR Part 11 (210/211, 820), GAMP, cGMP, GDP,

GLP, IQ, OQ, PQ, RTM, SOPs, Summary Reports, Audit Trails, LIMS

Testing Tools : HP Quality Center

SDLC : Waterfall, V-Model, Agile

Business tools : MS Office (Word, Excel, Power Point, Access, Visio),

Argus Safety 6.0 and Documentum.

WORK EXPERIENCE:

Invagen Pharmaceuticals (Hauppauge, NY)

Aug 2012 -Present

Role: Validation Analyst

Applications: Lab ware LIMS

Responsibilities:

. Customized and validated different components of the LIMS modules.

. Acquired and documented the business requirements.

. Prepared Validation Master Plan (VMP) for validating LIMS.

. Assisted in documentation and development of SOP.

. Responsible for analyzing and reviewing validation deliverables like

User Requirement specification and Functional requirement

Specification.

. Analyzed and reviewed Installation Qualification (IQ), Operation

Qualification (OQ), Performance Qualification (PQ) protocols.

. Developed OQ and PQ test cases.

. Drafted IQ test cases for verifying configuration.

. Developed and reviewed test scripts and test cases for automated and

regression testing.

. Executed the test cases stored in the Test Plan, imported locally to

the Test Lab in HP Quality Center and reported the defects.

. Generated Validation Summary Report to summarize and document all

validation activities

. Developed and reviewed Standard Operating Procedures (SOPs),

Requirement Traceability Matrix and Work Instruction for various

functionalities of the system.

. Used Defect Management grid of Quality Center in logging and analyzing

issues.

. Analyzed test scripts to check whether all functionalities have been

covered within the compliance of 21 CFR Part 11.

. Involved in good documentation practice of different stages of

validation life cycle in compliance with 21 CFR Part 11.

. Performed user acceptance testing to the check the various

functionalities of LIMS.

. Developed test scenarios for testing workflow paths in TrackWise.

. Proficient with Corrective Action Preventive Action (CAPA) workflow

including Investigation, Investigation Task, Action, Request, Request

Extension and Closure phases.

. Conducted GAP analysis and prepared Remediation Plan.

. Responsible for ensuring the compliance of GMP/GLP and FDA

regulations.

Amneal Pharmaceuticals (Brookhaven, NY)

Jan 2011 -Aug 2012

Role: Validation Engineer/Technical writer

Applications: EDMS / IRMS / Documentum

Responsibilities:

. As a member of Computer Systems Validation team, responsible for

documenting and reviewing all the validation deliverables.

. Performed regulatory and risk assessment of the computer systems.

. Used Documentum for storing the files.

. Authored VMP (Validation Master Plan) with risk based approach for

validation.

. Responsible for developing, analyzing and reviewing validation

deliverables like User Requirement specification and Functional

requirement Specifications.

. Responsibilities also include system qualification, assist in the

design, analysis and approval of IQ, OQ, and PQ protocol scripts.

. Responsible to get QA approval for validation deliverables and Vendor

Audit.

. Developed Performance Qualification for Citrix based tool MIRS -

IRMS.

. Coordinated the execution of Operational Qualifications Test Scripts

with different modules and specifications.

. Assisted in documentation and development of SOPs for IRMS 6.0

application.

. Designed, developed and implemented Test Plans using the detailed

business requirements document.

. Understood data mappings and Created Test Cases and procedures.

. Responsible for mapping of IQ to Design Specification, OQ to

Functional Specification and PQ to URS.

. Communicated validation approach and requirements to team and business

owner.

. Maintained the Traceability Matrix between Requirements, Test cases and

Defects.

. Extensively involved in Defect tracking, reviewing and analyzing and

reporting test result using HP Quality Center.

. Executed the test cases stored in the Test Plan, imported locally to

the Test Lab in QC and reported the defects.

. Performed change control by assessing proposed changes to validated

processes and identify the validation requirements necessary to

maintain the validation status after execution of the change.

. Conducted GAP analysis and prepared Remediation Plan.

. Participate and provide assistance and technical support on technical

project teams as subject matter expert on process validation

regulations/procedures.

. Critically review and provide support for validation sections of

regulatory submissions.

. Made sure all the documentation and records met 21 CFR Part 11

requirements.

. Submitting daily and weekly status reports to the manager and

performed timely escalations to the management.

Access Bio (Somerset, NJ)

Apr2010 - Dec 2010

Validation Analyst/Tester

Applications: CCMS / Medical Device TrackWise

Responsibilities:

. Reviewed and modified existing Standard Operating Systems (SOPs) for

Document management system, System Administration, Change Control

Procedures and Testing SOPs.

. Responsible for analyzing and reviewing validation deliverables like

Validation Plan, User Requirement specification, Functional requirement

Specification, System Design Specification document.

. Worked on change control documentation such as Change Request Form

(CRF's), Change Control Implementation Plan, Change Control Summary

Report.

. Involved in validating the TrackWise CAPA (Corrective Action

Preventive Action) Business Workflow.

. Validated the Integration of the CAPA Workflow with the other

business workflows and the interfaces for the TrackWise workflow.

. Developed Traceability Matrix to track the requirements during the

QA Testing Phase.

. Executed test cases to verify TrackWise functions, Workflow,

Queries, Scope, End-End flow Approvals, permissions and Reports.

. Developed IQ/OQ/PQ test plans, traceability matrices, deviation

forms and validation summary reports (VSR).

. Developed and executed IQ/OQ/PQ test plans and test scripts.

. Responsible for writing test plans, test scripts and executing them for

validation testing.

. Performed black box testing, positive testing, negative testing, front

end testing and regression testing.

. Reviewed and verified test results, identified and reported issues and

provided summary test reports.

. Documented Installation Qualification (IQ), Operational Qualifications

(OQ), and Performance Qualifications (PQ) documents using standard

templates.

. Authored and reviewed Requirement Traceability Matrix (RTM).

. Developed applicable test cases for integration test, system test and

acceptance test. Defects are tracked while processing testing and

reported using HP QUALITY CENTER and paper based manual testing.

. Expert level knowledge in reviewing and modifying standard operating

procedures (SOP).

Freyr Inc (Princeton, NJ)

Oct 2009 - Apr 2010

Role: Test Engineer

Application: AERS / Argus Safety 6.0

Responsibilities:

. Performed User and Business Requirements analysis to prepare

Validation Master Plan.

. Performed Global adverse effect case data management and regulatory

reporting to the industry using Argus safety.

. Established operating requirements and conducted tests to assure it is

operating under normal and worst case.

. Performed Integration, Positive and Negative Testing of the

application.

. Reviewed IQs, OQs, and PQs and documented results in compliance with

FDA regulations.

. Performed GAP Analysis and developed Remediation Plans.

. Performed System testing and documented results as part of IQs, OQs

and PQs.

. Updated and Maintained Required Traceability Matrix (RTM) as per the

changing requirements.

. Performed GUI and functionality testing using QTP.

. Developed Validation Summary Report (VSR).

. Ensured validation documentation for compliance with cGxP.

Natco Laboratories (Hyderabad, India) July 2006 -

Aug 2009

Role: Validation Engineer

Application: AERS

Responsibilities:

. Using backward/forward tracing of requirements and finding source

using Requirement Traceability Matrix (RTM) for the application.

. Wrote documents for reports that can be queried by type of adverse

event, disease and principle investigator.

. Wrote SOPs for training manual, storage and maintenance to comply with

21 CFR Part 11 and GLP requirements.

. Developed Test plan and written several test scripts for validation

testing.

. Wrote GAP Analysis report and Remediation Plan document.

. Reviewed and Documented IQ/OQ/PQ protocols.

. Performed Load Testing, Black Box Testing, GUI Testing and

Functionality Testing for the entire application.

. Developed Test Cases and Test Scripts to perform regression testing

using Win Runner.

EDUCATION:

. Bachelors in Pharmacy from Osmania University.

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