Engineer Project Manager

SANJEEV KUMAR NALLI

************@*****.*** Ph: 409-***-****

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Summary:

> Expertise in all aspects of the Computer Systems Validation Lifecycle

for compliance with FDA Regulations.

> Expertise in Technical Writing of Validation Protocols like

Installation Qualification (IQ), Operational Qualification (OQ) and

Performance Qualification (PQ), Validation Master Plan (VMP).

> Developed Standard Operating Procedures (SOPs) and trained users on

SOPs for many analytical instruments and manufacturing methodologies.

> Expertise in writing Test Plans, Test Scripts and Test Summaries and

Test Matrix and Requirement Traceability Matrix

> Experience in performing Gap Analysis for FDA compliance and

developing Remediation Plans.

> Experience in Validation Practices in GAMP, cGMP, cGLP, and cGCP.

> Experience in EDMS (Electronic Document Management System) using

Documentum 5i and Workspace.

> Experience in full Software Development Life Cycle using the Waterfall

Model and Rational Unified Process (RUP).

> Expertise in various types of testing like Black Box testing, White

Box testing, Load testing, Stress testing, Performance testing,

Security testing, Front end testing, Back End Testing, Security

testing, Positive testing, Negative testing, Sanity testing and System

testing.

> Expertise in Oracle database using SQL.

> Implementation, migration, custom development, and validation of

Laboratory Information Management System (LIMS) using SQL*LIMS.

> Highly motivated person with excellent analytical, interpersonal,

verbal and written skills.

> Experience in full Software Development Life Cycle using the Waterfall

Model and Rational

Unified Process (RUP)

> Experience in change control methodology using Trackwise.

> Experience in automated testing tools like Quick Test Professional

(QTP), Win Runner and Load Runner.

> Expertise in pharmacovigilance using Argus

> Expertise in technical writing of Validation Protocol, performing Gap

Analysis and developing Remediation Plans.

> Experience in handling HPLC, GC, UV- Vis, PXRD, LC-MS, TOC, DSC, TGA,

Autoclaves, Sterilizers, ovens, Cold rooms and Clean areas.

> Involved in conducting Manual Testing and Automated Testing.

> Experience with managing records using Oracle database using SQL

> Strong verbal and written skills for clearly delegating tasks to team

numbers and for effectively communicating results to management.

Technical Skills:

Life Sciences FDA Compliance, 21 CFR Part 11, IQ, OQ, PQ, RTM,

cGxP, LIMS

Testing Tools WinRunner, LoadRunner, Rational Suite, Silk

Languages Java, J2EE, C, C++, Visual C++, Visual Basic,

HTML, XML, UML, PHP and SQL

OS Windows NT, Windows 9x/ME/XP/2000, UNIX and Linux

Databases Oracle 8i, MySQL, MS Access, SQL Server

Networking Protocols TCP/IP, IP Multicast, UDP, CGI, HTTP, FTP, SMTP.

Internet Servers Apache, Tomcat and WebSphere.

SDLC Waterfall, RUP

Applications MS Word, Excel, Rational Rose, MS FrontPage,

Dreamweaver, SQL*LIMS, Documentum

Education:

> Masters in Chemical Engineering, Lamar University, Texas (March 2012-

August 2014)

> Bachelors in Chemical Engineering, India

Work Experience:

KBR

Process Engineer

October 2014-March 2015

Responsibilities:

> Analysed overpressure scenarios for Pumps, Compressors, Heat

Exchangers, Distillation Columns, Vessels and Utility for

manufacturing units using Aspen HYSYS V8.3

> Calculated the pressure drop in inlet/outlet piping of a relief device

using Pipe Flow according to Isometric drawings

> Performed Deficiency actions for Relief Devices and suggested possible

solutions.

> Prepared Relief Device Equipment data specification sheets

> Optimized the process data for desirable results using Aspen HYSYS, to

develop the refinery study reports.

> Reviewed Process Controls between various EPCs/ Units for IGCC and

Refinery through P&IDs, datasheets, HAZOP, control philosophies.

Pfizer Limited

May 2010-March 2012

Hyderabad, India

Validation Engineer

Responsibilities:

> Created Test Plans and uploaded in Quality Center, executed and

validated Test cases, validated the Test Reports generated by the LIMS

application for compliance with 21 CFR part 11 requirements

> Created and reviewed Functional Requirements Specifications (FRS) for

LIMS sample module.

> Prepared the Installation Qualification (IQ), Operational

Qualification (OQ) and Performance Qualification (PQ)

> Documented IQ, OQ, and PQ for different modules of Laboratory

Information Management System (LIMS), Applied Biosystems SQL*LIMS

> Supervised, wrote and reviewed the Test Scripts during System Test.

> Reported bugs using PIMS

> Responsible for User Interface Testing and User Acceptance Testing

> Wrote and analyzed the system specification covering User Requirements

> Analyzed Test Scripts to check if it has covered the functionalities,

which need to be in compliance with 21 CFR Part 11 rules set by FDA

> Developed and maintaining Requirement Traceability Matrix (RTM)

> Experience in preparing Deviation Reports when the test criteria did

not meet the acceptance criteria

> Performed Manual Testing to check the functionality of some GUI

screens

> Attended bi-weekly meeting with the project Manager and the Management

to brief them about the progress of the project

Dr Reddy's Laboratories Ltd.

June 2008- April 2010

Vishakapatnam, India

Validation Engineer

Responsibilities:

> Prepared and maintained the Validation Strategy Document (VSD),

Standard operating procedure (SOPs) and Validation Summary Report.

> Involved in Installation, Configuration and administration of

Documentum Content Server

> Create, maintain and document all required scripts and processes such

as SOPs, Installation and Design Documents using Documentum

> 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.

> Created and executed test cases for new TrackWise modules (Internal

and External Audits).

> Interacted with the users, TrackWise developer team to qualify

configured modules in TrackWise web team access and TrackWise

administrator

> Involved in preparation of Validation Deliverables (Validation Plan to

Validation Summary Report) of involved systems software and TrackWise

> Created and reviewed Functional Requirements Specifications (FRS) for

LIMS sample module.

> Implementation, migration, custom development, and validation of

Laboratory Information Management System (LIMS) using SQL*LIMS

> 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).

> Was involved in validation of Argus Safety by creating a Validation

Master Plan and IQ, OQ and PQ of the software system

> Involved in ensuring all compliant pre and post marketing safety

reports. Wrote test specifications, testing methodologies and user

manuals for Argus Safety

> Developed GAP analysis, Remediation Plan, maintenance of hybrid

systems, closed and open record systems.

> Drafted SOP's and trained users on these systems and the implications

and impact of 21 CFR Part 11 compliant data systems on the day-to-day

functions.

> Involved in preparing compliance report about the existing status of

cGMP, cGCP, cGLP.

> Regular interaction with designers, developers and system analysts.

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