Validation Engineer

K ESHA GAND H I VAL IDAT ION ENG I NEER

C: 908-***-****

E:***********@*****.***

SUM MARY:

Over 7 years of experience in Pharmaceutical and Biotechnology industr ies working as a

Validation Analyst/Business Analyst focusing on Computer System Validation, Process

Validation, Equipment validation, Inst rument Validation, Cleaning Validation and Software

Quality Assurance.

• In -depth knowledge and understanding of Validation L ife Cycle, Software Development

L ife Cycle (SDLC), Agile methodologies and Computer Systems Validation

• Strong knowledge about pharmaceutical/medical device regulations like F DA 21 CFR

Part 11.

• Extensive validating experience in FDA regulated environment and research

l aboratories with good understanding

of GxP: cGMP, G AMP4 and GAMP5, GDP, GCP, G LP standards and SOX regulations.

• S trong knowledge of the L ife Sciences industry for implementing Trackwise, assisted

i n blueprinting and design sessions to gather functional requirements for TrackWise and

configured TrackWise in accordance with technical and functional specifications.

• Worked with the laboratory and field personnel to optimize L I MS functions for the

l aboratory, field and QA/QC operations of the laboratory and with programmers and

analysts to develop custom programs, both standalone and L I MS interface.

• Proven ability to work as a technical wri ter and in preparing validation deliverables

and various summary reports.

• In depth knowledge of Oracle EBS, both Supply Chain and Financials.

• Performed R isk Assessment, Gap Analysis for FDA compliance and

developed CAPA Remediation Plans.

• Excellent oral and wri t ten communication skills

TECHN ICAL SKILLS:

21 CFR Part 11, cGXP (cGMP, cGDP, cGLP), GAMP, Quality System

Validation Regulation (QSR), Audit Trails, Standard Operating Procedures (SOP's)

Testing Tools HP Quality Center, Quick Test Professional, W in Runner, Test Director

Application Software Documented, Software Quality Assurance (SQA)

Databases Oracle, MS Access, SQL Server 2000

Operating Systems Windows 95/98/2000/XP and UN IX

Languages C, C++, SQL, SAS, SPSS

B usiness Tools M S Office Suite 2010

1

K ESHA GAND H I VAL IDAT ION ENG I NEER

C: 908-***-****

E:***********@*****.***

WORK EXPER IENCE:

Sr. Validation Engineer M ARCH 13 – T I L L

DATE

M edimmune,

MD

R esponsibilities:

• Reviewed and approved the SOPs documented for the validation protocols.

• Reviewed Validation Master Plan (VMP) and Validation Protocols (IQs, OQs and PQs)

i n detail.

• Wrote test scripts & deliverables for validating Documented.

• Reviewed test cases and scripts and documented the results as per the FDA

regulations.

• Involved in preparing compliance report about existing status of the cGMP, GCP and

G LP.

• Involved in preparing documentation for all aspects of the computer system validation

l ifecycle in accordance with FDA regulations, particularly System Requirement

Specification (SRS) and Performance Qualification (PQ) Specification.

• Followed Standard Operating Procedures (SOP).

• Developed a Validation Master Plan (VMP) to document the intent of validation effort

i n accordance with FDA regulation

• Gathered Traceability matr ix and Performed Gap Analysis and prepared Remediation

P lans to fix the gap identified.

• Assessed 21 CFR Part 11 requirements and analyzed organization’s current validation

s tate.

• Developed SOPs and URS, IQs, OQs, PQs for validation of Computer systems

specifically for the Electronic Records and Signatures.

• Maintain open communication with the L I MS team and Research customers to

maximize resource usage.

• Review tools for L I MS decision support to be used by the site. Analysis of L I MS

enhancements, t roubleshooting issues, second t ier application support and routine master

data configuration as required within the LabWare L I MS application.

• Conducted Vendor audits and prepared initial and final vendor audit reports.

• Gathered, documented, and obtained approval of Oracle EBS R12 business requirements

2

K ESHA GAND H I VAL IDAT ION ENG I NEER

C: 908-***-****

E:***********@*****.***

• Assisted the Project Manager in preparing Incident Reports as a part of testing

p rocess.

• Prepared and reviewed Validation Summary Repot (VSR) to summarize the overall

validation effort.

• Actively participated in the weekly touch base meetings.

ENV IRON MENT: M S Word, Track wise, Linux, XML, Apache Web server 21 CFR Part 11, MS

P roject plan, Crystal reports, Track wise, Agile, Oracle SQL Developer, MS Excel.

Validation Engineer D EC 11 –

F EB 13

P urdue Pharma L.P.,

S tamford, CT

Responsibilities:

• Developed, reviewed and executed the system related I Q /OQ and PQ.

• Verified Process Mapping to outline initial validation plan and process control strategy.

• Drafted new SOP’s and t rained a ll users on the systems, implications and impact of 21

CFR Part 11 compliant data systems on day-to-day functions.

• Reported Variances using Defect t racking tool and re-executed upon resolution using

Test Director.

• Assisted in generating the Er ror Report Form and resolving the errors encountered

d uring the testing effort and maintained the Error logs for the errors.

• Performed Statistical analysis for the FMEA r isk assessment and performed Fault

T ree analysis.

• Documented test execution report for Trackwise and prepared Requirement

T raceability Mat rix (RTM).

• Developed test scripts and test cases for automated and regression testing using HP

Quality Center.

• Performed Gap Analysis of the system taking into account the User Requirements and

System Requirements.

• Involved in auditing t he application for 21 CFR Part 11 compliance related

to E lectronic Signatures and E lectronic Records for a closed Track wise System.

• Reviewed, coordinated and maintained CSV Change Controls. Prepared Periodic

Reports for outstanding Change Controls.

• Reviewed and prepared P rotocols and Summary reports.

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K ESHA GAND H I VAL IDAT ION ENG I NEER

C: 908-***-****

E:***********@*****.***

• Provided reports regarding Validation activities and status of the project.

• Ensured Data M igration with data integrity and data security.

• Maintained Change control and qualification records and maintained paper archives,

controlled documents, and electronic databases in Track wise d uring migration. Routed

and archived documents.

ENV IRON MENT: H PQC, MS word, Excel, Track wise, Documented, Quality Center, Agile,

O racle SQL Developer, WinSCP, Oracle Database, FTP, MS Project plan.

Validation Analyst A UG 09 – NOV

11

Astellas Pharma,

N orthbrook, I L

Responsibilities:

• Hands on experience in formulating Installation Qualification (IQ), Operation

Qualification (OQ), Performance Qualification (PQ) for servers and network infrastructure

devices.

• Executed IQs, OQs and PQs to check the functionality of the system

• Proficient in wri ting Requirements Traceability Mat r ix (RTM) to t rack requirements

d uring the entire t esting p rocess.

• Wrote Script and documented deviations to qualify Servers and Network Infrastructure

Devices (Routers/Switches).

• Documented Validation P lan, Test Cases and Test Procedure based on Business

Requirements with Program Manager, System Owner, System Administrators and SMEs.

• Designed and maintained Standard Operating Procedures (SOPs) such as Backup and

Recovery, Local Area Network Security, Active Directory Access, VM Ware Help etc.

• Involved in reviewing and maintenance of Oracle EBS supply chain modules and

exposure to ERP & CRM systems.

• Involved in creating Statement of Work (SOW), revision to the existing SOP’s and

establishment of internal company standards.

• Responsible for ensuring the compliance of GMP/GLP and FDA regulations

ENV IRON MENT: Quality Center 9.0/10.0, TOAD 7.5, Oracle 10.2, Java 1.6, Tomcat 6.0,

C rystal reports, MS Excel

4

K ESHA GAND H I VAL IDAT ION ENG I NEER

C: 908-***-****

E:***********@*****.***

Validation Specialist: S EP 07

– J ULY 09

M idland Pharmaceutical, LLC, Kansas

C ity, KS

Responsibilities:

• Reviewed business requirements and f unctional requirements of the project

• Developed t est plan, test cases and test scripts to validate p roduction planning and

order requirements f unctionalities.

• Involved in regression testing when new features are added and bugs are fixed

• Maintained Requirement Traceability Mat r ix (RTM)

• Involved in end to end manual testing of the application

• Performed and implemented quality reviews of product documentation.

• Updated Work Inst ructions for utilizing the functionalities of the equipment.

• Documented subsequent updates to lot functionalities in a maintenance plan.

• Generated SQL Queries i n Documented A dministrator to run the audit t rail reports.

• Reviewed Oracle EBS suite module solutions based on functional specifications, and

p roviding enhancements.

• Performed configuration testing i nvolving different types of browsers like Netscape and

E xplorer

• Participated in discussions for validation approach meetings, technical meetings, user

g roup meetings and project status meetings.

ENV IRON MENT: Quality Center, GxP, M icrosoft Office tools, Oracle, SQL server, UN IX.

EDUCAT ION:

BSC I N APPLIED NUTRITION

5

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