Validation engineer

Amruta Divekar

Email id:**********@*****.***

Objective:

Cell#:248-***-****

Seeking a challenging position as a Software Validation /Quality Assurance

Lead that will effectively utilize my skills and expertise in making

productive contribution in the pharmaceutical and medical device

manufacturing industry

Summary:

. Extensive experience of all the aspects of Software Validation, Testing

Life Cycle, with emphasis on manual/automated testing.

. Expertise in all the stages of the software development life cycle (SDLC)

and QA methodologies.

. Excellent experience working with Documentum (Document Management

System).

. Proficient in manual and automated testing, wrote and designed validation

master plans, test cases, test scripts, Test strategy and test

procedures.

. Gained experience in Load, Stress, Performance, Regression, Smoke and

System/end to end testing.

. Excellent working knowledge of Computer System Validation

(CSV),developing and reviewing Installation Qualification(IQ),Operational

Qualification(OQ) and Performance Qualification(PQ).

. Proficient in dealing with Standard Operating Procedures (SOP's),Test

Plan, Track Wise modules for CAPA and Complaints Handling, Laboratory

Management System(LIMS).

. Configured, Commissioned and Validated, TrackWise,SAP report, Mercury

report, Crystal report, and SQL*LIMS.

. Experience in developing Requirement Traceability Matrix (RTM).

. Competent in Quality System and Standard (cGLPs,cGCPs,and

cGMPs),21CFR(Part 11, 210,211,820),QSR, Gap Analysis and Remediation

Plans.

. Strong Analytical Skills with high level of energy and creativity also a

quick learner and committed to continuous self-improvement.

. Excellent communication and presentation skills and have the ability to

work efficiently in teams and independently as well.

EDUCATION:

Master of Science in Biomedical Engineering, Wayne State University,

Detroit, Michigan.

Bachelor of Engineering in Instrumentation and Control Engineering,

University of Pune, India

Technical Skills:

Automated Testing Tools: HP Quality Centre, Solution manager,HP service

centre

Computer System Validation: 21 CFR Parts(11,210,211,820),cGxPs(cGCP, cGLP,

cGMP),IQ,OQ,PQ,SOP's,Audit Trails.

Operating Systems: Windows ('95,'98,2000,XP,Vista,NT).

Other Tools: MS Office(Word, Excel, PowerPoint),Matlab, LIMS

Experience:

BD

Corporate Functions,Franklin Lakes,NJ

April 2012 till date

IT validation Engineer

BD (Becton, Dickinson and Company) is a global medical technology company

that is focused on improving drug delivery, enhancing the diagnosis of

infectious diseases and cancers, and advancing drug discovery. BD develops,

manufactures and sells medical supplies, devices, laboratory instruments,

antibodies, reagents and diagnostic products through its three segments: BD

Medical, BD Diagnostics and BD Biosciences. It serves healthcare

institutions, life science researchers, clinical laboratories, the

pharmaceutical industry and the general public.

Responsibilities:

. Part of the validation and compliance group at BD

. Validation lead for majority of the ERP global projects like the

SAP ECC 6.0,Non ERP Track Wise, LIMS/MODA, Calibration management

system(BMRAM),Clinical Document management system, Electronic lab

notebook, Clinical trial data management system upgrades, HP service

centre upgrades, Supplier Information Management Tool(Aravo),Veeva

vault implementation

. Providing guidance to teams on global procedures and guidance's used

in BD

. QA author, reviewer and approver on the validation package of existing

as well as new implementations.

. Validation specialist on production maintenance projects for current

applications at BD.

. Conducted vendor audits and was in charge of the computer systems

software validation part of the audit for Lonza( Vendor for MODA) and

Labware(vendor for LIMS) .

. Experience on projects with SAAS approach(software as a service) for

projects Aravo and Veeva

. Validation support for SAP 6.0 implementation at BD.

Philips Healthcare, Andover, MA

Dec 2009-Feb 2012

Quality Systems Validation Engineer

With a growing presence in cardiology, oncology, and women's health,

Philips healthcare focus on the fundamental health problems with which

people are confronted, such as congestive heart failure, lung and breast

cancers and coronary artery disease. The focus is to deliver value

throughout the complete cycle of care: from disease prevention to screening

and diagnosis through to treatment, monitoring and health management.

Responsibilities:

. Part of Quality and regulatory program at Philips healthcare.

. Individually handled User acceptance testing of Mercury reporting

module, which is the customer feedback management system in place in

Philips.

. Validation lead on Mercury-Customer feedback management tool,

reporting module ( dec 2009-feb 2010)

. Validation lead on Corrective Action and Preventive action (CAPA) (Feb

2010- Feb 2012)

. Validation lead on Auto data load to Track Wise project, where Service

order review process in Complaint handling was automated( Jan 2011-

May 2011)

. Validation lead on the Adverse Event Reporting project, which involved

a report to be developed with SAP reporting solution.(May 2011-July

2011)

. Validation lead on Track Wise CAPA Remediation project ( july 2011-

Sept 2011).

. Validation lead on Track Wise Heart Stream project, where enhancements

were done to functionality in Track Wise for a Philips business

unit.(Nov 2011-Feb 2012)

. Authored all validation deliverables like Validation Plan, UAT

protocols, UAT summary report, Validation summary report.

. Worked closely with IT as well as Business groups.

. Document review for Used cases, business requirements, as well as

system integration test protocols.

. Was actively working on remediation project in Philips, where the

entire Track Wise application was revalidated.

. Excellent experience working with Documentum (Document Management

System).

. Proficient in manual and automated testing, wrote and designed

validation master plans, test cases, test scripts, Test strategy and

test procedures.

. Gained experience in Load, Stress, Performance, Regression, Smoke and

System/end to end testing.

. Excellent working knowledge of Computer System Validation (CSV),

developing and reviewing Installation Qualification (IQ), Operational

Qualification(OQ) and Performance Qualification(PQ).

. Proficient in dealing with Standard Operating Procedures (SOP's), Test

Plans.

. Experience in developing Requirement Traceability Matrix (RTM).

Wyeth Pharmaceuticals, Richmond, VA

Aug 2009 - Dec 2009

Validation engineer/systems analyst

Wyeth, formerly known as American Home Products (AHP), is one of the

largest pharmaceutical companies in the world. It is a research based

global pharmaceutical company responsible for the discovery and development

of some innovative medicines.

The company is based in Madison, New Jersey with many research based

offices all over U.S. They are known for manufacturing the over-the-counter

(OTC) drugs Robitussin and the analgesic Advil (ibuprofen), as well as the

prescription drugs Premarin and Effexor.

Responsibilities:

The project in Wyeth involved performing the periodic reviews of the

computer servers

. Gathering all the documentation like the IQ/OQ/PQ, change controls,

validation plans, summary reports for each server.

. Analysis of these documents along with system owners.

. Following a standard procedure of the company to check for compliance of

these documents with the latest standards followed in the company.

. Same procedure followed for dealing with infrastructure compliance

checking.

. Preparation of the final periodic review document.

Contact this candidate