hire IT people

WegetITdone!

We provide IT Staff Augmentation Services!

Software Validation (csv)/ Quality Engineer

Resume
     4.00 /5 (Submit Your Rating)

SUMMARY:

Professional experience with Validation of Software, Computer Systems/Testing used in

Laboratories, Clinical, Pharmaceutical/ Medical Devices and Biochemical Industries. Excellent
working experience in validating the computer systems in as per CAPA, FDA regulations and
GLP, GMP, GCP guidelines. Contributed to the success of Inform, Clintrial, Confidential
applications and managing the team members by motivating the team and by conducting
meetings, periodic review.

 Excellent Experience in Validation of Computer applications such as Inform, Clintrial,

Clintrace, Oracle Confidential, Routers, Switches, Remedy, Sample Manager,
Documentum, LIMS, Data Integrity, Pharmaceuticals/Biologics
 Experience in Developing and enhancing the Standard Operating Procedures (SOPs) as a
part of the SOP program.
 Expertise in conducting Risk Assessment, 21 CFR Part 11 Assessment, Security
Assessment, and documenting as per GAMP 5 guidelines. Heavy emphasis on Computer
Systems Validation, Instrument/Equipment Validation, Cleaning and Process Validation
and Software Quality Assurance with profound knowledge of FDA regulations,
documenting validation protocols, Documentum, LIMS, AERS
 Develop Software Test Plans (STP) and protocols (both manual and automated using
scripts), Software Requirement Specifications (SRS), Software Development Plan (SDP),
Software Design Specifications (SDS), Customer Requirement Specifications (CRS),
Software Configuration Control (SCC), and software manuals.
 Hands - on Test Method Validation (TMV), and R&D experiences.
 Worked with many Automation and process systems like DCS, PLC, HMI, custom
software systems etc. for unit operations like compounding, batching, cleaning, freeze

https://www.hireitpeople.com/resume-database/82-quality-a es/76675-software-validation-csv-quality-engineer-resume 09/01/24, 9 26 PM

Page 1 of 5
:
s
 drying, SIP, filling, packaging.
 Develop test scripts and execute V/V software tests both automated (Rational Visual Test
6.0) and manual.
 Expertise in using Documentum, Sharepoint, TrackWise, Laboratory Information
Management System (LIMS), Windchill, HP Quality Center, Adverse Event Reporting
System (AERS).
 Experience in documenting User Requirements Specifications (URS), Functional
Specifications (FS) and Design Specifications (DS) documents.
 Expertise in documenting Design Review (DR) and Qualification Protocol (QP), Technical
Writing. Excellent experience as Validation Specialist and in-depth involvement in writing
test scripts for Installation Qualification (IQ), Operation Qualification (OQ) and
Performance Qualification (PQ).
 Experienced in Laboratory Method Validations, Process Validations, Cleaning validations,
Building Automations Systems, Microbiology Laboratory Validations, Facility
Commissioning, Legacy Equipment Validations etc.
 Excellent understanding of Software Development Life Cycle (SDLC).
 Hands on experience in Manual Testing of various applications and developed Test
Plans, deliverables, entry and exit criteria and documented the User Acceptance Testing
based on the User Requirements and also assessed the risk and security aspects for the
application.
 Well versed with MS O"ce. Excellent oral and written communication skills.

TECHNICAL SKILLS:

Methodologies: Agile, Waterfall, V-model, Spiral

Regulations GMP: FDA 21CFR-Part 211, GLP (21CFR Part 58, QSR (21CFR Part 820), ERES
(21CFR - Part 11, Gamp 4/5, SOX

Software: MS O"ce, MS Project, MS Visio, Labware LIMS, Watson LIMS, Sharepoint, eRoom,
Oracle Argus Safety AERS, Spectrophotometer, Astra Data Acquisition software, Agilent
Chemstation, Empower, SQL, TrackWise, LIMS, Documentum (V 6), Windchill (V 9.1), MATLAB,
JMP, SAS

Testing Tools: Quality Center, Crystal Reports, Win Runner 6/7.6, Load Runner, Test Director

Programming: C, C++, SQL, PL/SQL, Visual Basic, PL7 ladder logic

O.S: Unix, Linux, Windows DOS

Database: Oracle 8/9i, MS Access, SQL

PROFESSIONAL EXPERIENCE:

https://www.hireitpeople.com/resume-database/82-quality-a es/76675-software-validation-csv-quality-engineer-resume 09/01/24, 9 26 PM

Page 2 of 5
:
s
 Confidential, Mahwah, NJ

Software Validation (CSV)/ Quality Engineer

Responsibilities:

 Documented URS, IQ, OQ and PQ for Version Control and Data Solutions
systems. Reviewed URS and FRS documents for Jira application. Documented Validation
Plan, Test plan, Functional Specifications, Qualification Protocol and Test cases.
 Participated in meetings with IT Project Manager, Validation Analyst in order to track
project status and to verify the project progress complies with the project schedule.
 Created templates, procedures, SOPs and manuals for validation including infrastructure
qualification, analytical instruments, lab equipments, spreadsheet and SAP based
applications.
 Created Data Migration scripts and monitored the extraction and transfer process.
 Gathered requirements, reviewed and approved Requirements Specification document
as part of IT tools validation. Reviewed and approved related documents such as
Validation Plan, Test plan, Requirements Specification, Functional Specifications,
Qualification Protocol, Test cases.
 Used Quality Center for managing Requirements, Test Plan and Test Cases. Wrote Test
plan, validation plan for the validation of IT tools.
 Reviewed the Functional Specifications document for DOORS. Reviewed the SOPs and
policies and regulations.
 Involved in Validation of the labeling application and associated hardware in accordance
with FDA's 'General Principles of Software Validation' and 21 CFR part 11 compliance
 Authored and reviewed Design Specifications and Functional Specifications as per the
needs of the client sites.
 Developed Validation Protocols (IQ, OQ, PQ) as per the specifications and requirements.
 Responsible for handling the objective evidence, managing the associated deviations
and escalating the system issues.
 Involved in analyzing possible Issues, Risk assessment and mitigation and maintaining
Deviation Records.
 Initiating and updating Change Control tickets for CAB and CCB reviews as per Quality
System Impact procedures.
 Authored, reviewed and maintained Traceability Matrix for various testing cycles
planned for multiple global level site deployments.
 Developed Training Plans and SOPs as per FDA Quality System Regulations (QSR), ISO
13485, ICH Q10.

https://www.hireitpeople.com/resume-database/82-quality-a es/76675-software-validation-csv-quality-engineer-resume 09/01/24, 9 26 PM

Page 3 of 5
:
s
  Participated in the production support activities and Continual Service Improvements
(CSIs) of the systems and processes.
 Trained Testers and Business Users on Test Script Execution and Evidence Handling as
per FDA's Good Documentation Practices.
 Involved in management, maintenance, retrieval and archival of documents and records
electronically using SharePoint.

Confidential

Validation Analyst
Responsibilities:

 Reviewed Change Requests for di#erent bugs and fixes those arise during the Oracle
Confidential Release Management Project.
 Reviewed, organized Change Requests and approved after verification of completeness
of documentation.
 Assessed Quality, Compliance, and Application, Business and Infrastructure impact of
the Change and also the impact if the fix is not moved to Production.
 Assessed Risk and prioritized Change Requests and ensured the Change Requests are
moved accordingly.
 Drafted Test Plan, Implementation Plan and Recovery/Back out Plan for Oracle
Confidential based application.
 Worked with Web sphere Customer Center for maintaining record of the customers
across the enterprise. Conducted Load testing and monitored performance scenarios
with HP LoadRunner.
 Worked with the Development team, Change Management team, Technology, Business
and Compliance approval teams to move the Change Requests to di#erent
environments.
 Worked with the developers in creating Setup Logs, Patch Logs for the fixes that involved
Setups and Patches.
 Reviewed and enhanced Change Requests created by the Change Control team.

Confidential

Validation Specialist/Test Analyst

Responsibilities:

 Monitored the testing conducted by QA dept. and documented the Validation Summary
Reports.The project at Medimmune mainly involved working on Regulatory applications.
 Involved in coordinating the approval of IT for Insight Publisher Upgrade through

https://www.hireitpeople.com/resume-database/82-quality-a es/76675-software-validation-csv-quality-engineer-resume 09/01/24, 9 26 PM

Page 4 of 5
:
s
 authorized Request for Change- RFC.
 Co-ordinated with Regulatory Operations to open a new Validated System Change
Request in TrackWise to document the implementation of Insight Publisher Upgrade.
 Drafted the Installation Qualification Protocol (IQP) as per release notes provided by for
implementation of insight Patch.
 Involved in review, update and pre-approval of IQP and OQP by uploading the
documents in Aegis EDMS involving System Owner, Validation, Information Technology,
and Quality Assurance
 Involved in the post execution documentation (as per GDP) of executed IQP, and OQP
and coordinated with System Owner, Validation, Information Technology, and Quality
Assurance for post approval.
 Assured that the VSCR (TrackWise) and RFC (SharePoint) are in appropriate status to
ensure IT Compliance as per Medimmune standards to comply with FDA regulations.

 Report an issue

https://www.hireitpeople.com/resume-database/82-quality-a es/76675-software-validation-csv-quality-engineer-resume 09/01/24, 9 26 PM

Page 5 of 5
:
s