Quality Control Computer Systems

HARIPRIYA KONDURU

Mobile:091******** ~ Email: ***********@*****.***

PROFESSIONAL PROFILE

1.I am technically competent engineering professional having 10+ years of work experience in Pharmaceutical Industry/ IT Lifesciences with the core strengths in areas of IT Compliance Associate of LIMS, Expert in CSV(Computer Systems Validation) practices in the pharmaceutical manufacturing industry with core expertise in Manual testing, Authoring Test Scripts, Exposure in Software Development Life Cycle (SDLC), Defect Life Cycle Management, Qualitative & Quantitive analysis, Documentation simplification.

2.Having 8+ years of work experience in Labware Laboratory Information Management System (LIMS) and 1 year Experience in ERP Domain(SAP).

3.Worked as an IT Compliance Associate with Hospira, a Pfizer company, I am engaged as Subject Matter Expert (SME) for Computer Systems Validation and, working with Pfizer Provided Technical support to Labware LIMS (Laboratory Information Management System) in Quality Control, setting up procedure and system as per compliance, undertaking troubleshooting and maintenance activity to provide 100 % paperless Laboratory. Equipped with knowledge of various quality aspects and cGMP documentation guidelines, Computer Systems validation trained, knowledge of manufacturing & GMP environment for sterile and Non-sterile manufacturing.

4.Having good exposure on Quality Control / Manufacturing systems to perform Validation activities as per 21 CFR part 11 Compliance.

5.Worked with Merck account in the static data migration as per the client requirement.

6.Worked with Sanofi project in the support of application LIMS and CSV.

7.Worked with BIOGEN Client as a LIMS Consultant for ELN development through ITS Service Now for Change Management, Release Management, Incident Management.

8.Working with Takeda Pharmaceutical’s Client as a IT Consultant in Master Data Configuration, Migration activities to different environments, Issue tracking and resolution, Bug Fixing and To performing Validation activities to deploy in higher environments ( Validation, Production)

PROFESSIONAL EDUCATION

Bachelor Of Computer Science & Engineering (B.E-CSE) From R.M.K. Engineering College

PROFESSIONAL EXPERIENCE

Working as a Application Development Specialist in Accenture Solutions India Pvt. Ltd, Chennai from Sep 2021 to till date.

Worked as a Associate in Cognizant Technology Solutions India Pvt. Ltd, Chennai from October 2018 to Sep 2021.

Worked as a IT Compliance Associate in Pfizer Pharmaceutical’s India Private Limited, Chennai from January 2016 to October 2018.

Worked as a Software Engineer in Quadrant Four Solutions India Pvt Ltd, Chennai from January 2013 to July2013.

Worked as a Software Engineer in Systems Technology Group India Pvt Ltd, Chennai from January 2010 to November 2010.

Worked as a Software Developer in KHEC Solutions India Pvt Ltd, Chennai from August 2008 to December 2009.

Worked as a Software Engineer in Devsquare India Online Services Pvt Ltd, Bangalore from July 2007 to Feb 2008.

Core competencies

Labware LIMS, SAP, Computer System Validation, 21 CFR Part 11, Quality Management System, Risk Assessment, Client Focus, Documentation and Testing, Cross functional Collaboration, Change Management, Release Management, Incident Management, SQL SERVER, GAMP5, Proposes effective CAPA, Staff training and Development.

PROJECT EXPERIENCE

Projects in Accenture:

Takeda Client: Working as team member.

1.Master Data Configuration and Migration as per business requirement.

2.Building Analysis configuration, Instrument Configuration, Product configuration.

3.Writing component calculations and configuration based on client requirement.

4.Incident Handling and Resolving - L2 and L3 support.

5.Handling Change Management and Release Management through ITS Service Portal.

6. To Performing Validation activities related to Deployment and Installation Configuration to Validation and production environments.

7.Part of Knowledge Management team- KT sessions for the New Joiners’.

Labware LIMS (Laboratory Information Management System):

BIOGEN Client: Worked as a LIMS Consultant in ELN Development.

1.Developing ELN workbook-based on the Client requirement.

2.Incident Handling and Resolving - L3 support.

3.Change Management – Change creation to release in Validation and Production environments.

4.Deployment and Installation Configuration packages in Staging, Validation, Production environments.

Projects in Cognizant:

Labware LIMS (Laboratory Information Management System):

Merck Client: Worked as a team member in static data migration.

1.Analysis configuration and Product configuration

2.Instrument Configuration.

3.Writing component calculations and configuration.

4.Sample Plan Configuration and logging samples to user for verification.

5.Unit Testing, Debugging, Bug Fixing, Issue Resolving.

6.Static Data Migration to different environments.

7.Crystal report design and development using report tool.

8.Writing Format Calculations in LIMS.

9.LIMS basic functions.

10.Error handling in LIMS.

Sanofi Client: worked as team member.

1.Incident Handling and Resolving - L2 and L3 support.

2.Change Management.

3.Deployment and Installation Configuration.

4.Master Data Migration and deployment to validation and Production environments.

5.LIMS basic functions.

6.Error handling in LIMS.

Projects in Hospira, a Pfizer company:

Labware LIMS (Laboratory Information Management System):

1. Implementation of Labware LIMS in Quality control laboratory for finished product testing.

2. Pharma Template V4 - System Overview and General Functions.

3.LIMS System Validation as per 21 CFR part 11 regulatory requirements.

4.Static data configuration and verification.

5.Laboratory workflow, data tracking, audit trails.

6.Periodic review of audit trails.

7.Label printing and verification.

8.Lot Management, Sample Management, Folder Management.

9.Data Back-up activity and data backup verification.

10.Perform basic or complex configuration of laboratory information systems.

11.Data Migration from one server to another.

12. Produce quality materials that maintain the validated state of the system.

13. In FDA regulated environment, ensure that all activities adhere to relevant policies, SOPs, and regulations.

Projects in Hospira, a Pfizer company:

SAP ERP (SAP- Enterprise Resource Planning)

1.Co-ordinated with cross functional teams to validate SAP application as per 21 CFR part 11 regulatory requirements.

2. Involved and Prepared Validation Plan with Onsite team.

3. Involved in site level Static data configuration and Verification.

4. Involved in Configuration of Label printers to SAP Application.

Projects in Systems Technology Group.

Title : Genuine eService (Ges)

Client : FORD

Role : Software Developer

Platform : Java 1.5, Web Services (SOAP), JSP 2.0, Oracle 10g, RSA7.0, and Ford Frameworks.

Description:

Genuine eService (GeS) is a suite of online tools that provides Ford-Lincoln-Mercury (FLM) dealers' customers the convenience of scheduling vehicle service online 24/7. The GeS consumer facing web site is delivered through the dealer proprietary site or Dealer Connection site. There is an administrative web site for dealers where the dealers can customize the GeS calendar, confirmation message and set their preferences.

GeS consumer facing allows customers to schedule an appointment with a dealer for their vehicle repair, schedule maintenance and/or recall request. Integrated dealers' customers can also check the status of their vehicle service.

Responsibilities

1. Development of view Part of the vehicle information.

2. Requirement Gathering.

3. Involved developing Ford Frameworks.

4. Developing Legacy Module for the Dealer Admin Site.

5. Modules involved in non-Integrated dealerships.

6. Testing the web services using Soap UI Integration tool.

7. Performing manual and Unit Testing and Bug Fixing .

Title : Web-Based Project Management & Collaboration Solution System

Client : University Technology Mara (UITM), Govt of Malaysia

Role : Software Developer

Platform : Java, Struts1.3, JSP, Tomcat 5.5, SQL, Eclipse 3.1, SQL

Description

This project is to develop and implement Web-Based Project Management & Collaboration Solution System (W-PMCS) to monitor all the construction projects that are undertaken within UTM (University Technology Mara), Malaysia. The Project Monitoring & Collaboration System (W-PMCS) is used by the project members in organizing project member’s (user management, information), communication (discussion groups, news system, chat, and messaging support) and project management (project data, tasks, to-do lists, resource management). Project Management module allows the authorized project members to feed in details regarding the project and the task assigned to the resources allocated under the respective project. This project enables the project users to view the detailed project status of the ongoing projects dynamically.

Responsibilities

1.Involved in developing Agency and Project Module

2.Designed the part of Database for the application.

3.Implemented new technical features such as display tag to minimize manual coding.

4.Client facing issues and resolving coding bugs.

5.Designed the prototype of the application using HTML pages.

Title: NUC library

Client: Govt of Malaysia, Malaysia

Role: Java Developer

Environment: Marc4J Editor, JavaScript, XML, Eclipse plugins, Windows 2000

Description

National Union Cataloguing (NUC), which has fifty one libraries, Editing error tags of library records with correct data like book name, year of publication, author of book, Information related to book are edited using Marc4J editor java script, xml tools and Eclipse Plugins.

Responsibilities:

1.Written script for Marc conversion using XML, JavaScript.

2.Written java classes to read records from Marc file.

3.Connected with database checked valid & invalid records using eclipse plugins& Marc4JEditor.

4.Involved in integration of the different libraries to run the entire application.

Title : Devsquare Online

Client : Devsquare online India Pvt Ltd, Bangalore, India

Role : Software Developer

Platform : Java, JSP,,html, Servlets,,java script, Oracle 9i, Tomcat 4.1

Description

DevSquare is an online development environment where you can write, compile and execute programs. You do not need any local installation. DevSquare helps you learn programming concepts, test yourself by attempting programming questions, and also develop complete applications online. DevSquare supports Java, J2EE, C#.Net, ASP.Net, C, C++ and Database programming.

Responsibilities

1.System study-reviewing the existing system architecture.

2. Implementation &Integration

3. Testing, bug fixing trouble shooting.

4. Development of JSP pages

5. Development of JDBC work.

6. Performing Unit testing.

PERSONAL DOSSIER

Permanent Address: BB4, B Block, 5th Floor, Mukha Triveni Apartments, Thiruverkadu, Chennai – 600077.

Declaration:

I hereby declare that all the information furnished above is correct and true to the best of my knowledge.

Place: Chennai

Date: 10-01-2024

(HARIPRIYA KONDURU)

Contact this candidate