Quality Manager Project

Professional Summary

Validation engineering experienced in the Computer System Validation, Equipment Qualification, Lab CSV etc, as per U.S FDA regulations.

Solid understanding in the Software Development Life Cycle (SDLC), as well as Software Methodologies such as Waterfall and Agile in terms of development and testing.

Experience with the GAMP 5 Guideline, including documenting project and validation deliverables, gathering business, functional, and system requirements, establishing testing and validation protocols (IQ/OQ/PQ), and summarizing reports and final validation packages.

Superior understanding of GAMP, GxPs (GCP, GLP, and GMP), and the Electronic Records, Electronic Signatures, and Audit Trails regulations found in 21-CFR Part 11.

Expertise in developing and revising User Requirement Specifications (URS), Functional Requirement Specifications (FRS), and Design Specifications (DS) in accordance with FDA guidelines and regulations.

Prepare and review Test Plans, Validation Protocols (Installation Qualification - IQ, Operational Qualification - OQ, Performance Qualification - PQ), Test Summary Reports, and Requirement Traceability Matrix (RTM).

Experience analyzing all SDLC documentation, processes, and SOPs for compliance with FDA standards.

ERP Systems, Laboratory Information Management Systems (LIMS), Electronic Data Capture (EDC), and Adverse Events Reporting Systems are all skills you'll need (AERS).

Expertise in the preparation of all needed papers for the Computer System Validation (CSV) lifecycle, including the Validation Master Plan (VMP), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Validation Summary Report (VSR).

Experience assessing Corrective and Preventive Actions (CAPA) and flagging and recommending mediation approaches to alleviate noncompliance.

Using HP Quality Center and ALM, I tracked and documented Change Requests.

Working with Track Wise to create and approve Validated System Change Requests is a plus (VSCR).

Experienced in the development of Standard Operating Procedures (SOPs), Business Processes (BPs), and work instructions (WIs).

Working knowledge of FDA-compliant computer system validation, including Change Control Management System (CCMS), Electronic Document Management System (EDMS), Quality Management System, and Life Sphere eTMF (CTMS).

Experience coordinating and facilitating the achievement of project goals.

Extensive experience with GXP audits, particularly in an onsite context; knowledge of QMS systems, electronic document management systems, and vendor assessment reports.

Experienced in monitoring and tracking the system for any Change Controls, Product Complaints, Deviations, and CAPAs for root cause analysis, as well as providing support to the Quality Organization environment.

Skills

Validation

21CFR Part11 (210, 211, 50), cGXP (GLP, GMP, GCP), Validation, IQs, OQs, Qs, SOP, Remediation Plans, RTM, Gap Analysis, Audit Trails

SDLC Methodologies

Agile, Waterfall, Spiral and V-model

Applications

LIMS, AERS, ARGUS, QMS, LMS, ERP.

Operating Systems & Server’s

Windows server 2008R2/12 R2, Windows 7/8/10

Testing and Tracking tools

Rational Quality Manager, HP ALM, HP Quality Center, Track Wise and LIMS

Work History

Client : Ortho Clinical Diagnostics, Raritan,New Jersey Role: Computer System validation engineer (Quality Assurance and Quality Compliance ) Dec2022 -Till date

Responsibilities:

Documented URS, FDS, Compliance plan, Compliance Analysis, Validation Plan for LabPAS Replacement project.

Gathered and reviewed user requirements from business process owners.

Participated in Risk Assessment meetings with Business Process owner and production support team. Managed compliance risk assessments and executed compliance reviews to increase the efficacy of regulatory compliance risk management.

Participated in meetings with IT Project Manager, Validation Analyst to track project status and to verify the project progress complies with the project schedule.

Reviewed the SOPs, policies, and regulations.

Worked as Quality system Author and created and routed the documents in Windchill PLM.

Developed validation Protocols IQ, OQ, PQ and test cases, Validation Summary Report for LabPAS Replacement project.

Support Change management activities for CGMP computer systems (ERP) and other related activities.

Involved GAP Analysis, Root Cause Analysis, Corrective and Preventive Action (CAPA) Reporting, Handling and closing of identified defects and findings.

Performed GXP assessment and propose mitigation activities.

Consult project team on quality management and involve in defining the validation strategy, risk management for GXP validation systems.

Involved and prepared Risk Assessment document for Empower3 chromatography data system.

Prepared Software IOQ, PQ for Empower3 System .

Client: Zimmer Biomet, Indianapolis, IN Jan 2022- Nov 2022

Role: Computer System Validation 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.

Created templates, procedures, SOPs, and manuals for validation including infrastructure qualification, analytical instruments, lab equipment’s, 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.

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 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.

Regeneron, Troy, NY Feb 2018 – Dec 2021

Role: Computer System Validation analyst

Responsibilities:

LIMS administration,upgrade,and system enhancement and Labvantage LIMS implementation.

Developed and validated complex crystal reports for LIMS system.

Reviewed Change Requests for different 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 the impact if the fix is not moved to Production.

Assessed Risk, 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 different 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.

Supporting the testing team in finding the root cause of any issues and executing corrective and preventive steps.

New CSV trainers are being educated.

Supporting and approving all change control requests

Through the change control management process, I was involved in end-user application version control.

Managing application bugs and patches as part of the Change Control process to document, correct any deviations, and efficiently manage version control.

Shantha Biotechnics, India Jan 2013 – April 2014

Role: Validation Analyst

Responsibilities:

Gathered and reviewed user requirements from business process owners.

FRS (Functional Requirements Specification) and DS (Design Specification) documents were reviewed.

Reviewing Vendor Assessment Reports and developing SOP blueprints based on URS and FRS drafts.

Using the Learning Management System, I completed all GCP and 21 CFR Part 11 training documents.

Validation deliverables such as the Validation Plan, Risk Assessment, Quality Assurance Review, and Validation Summary Report were analyzed and reviewed in accordance with 21 CFR Part 11 and GxP FDA Compliance Regulations.

For sample management and analysis, a Learning Management System (LMS) was used.

Verifying the algorithm used in the Spread sheet application to demonstrate that correct calculations are being produced.

Verifying the algorithm used in the Spread sheet application to demonstrate that correct calculations are being produced.

Creating test cases/scripts (IQ, OQ) for verification against specifications in order to guarantee that the LMS application is fit for purpose.

UAT (User Acceptance Testing) for the CTMS application was coordinated.

Test Cases, Test Scripts, and Test Summary Reports were all reviewed.

worked on the system's risk assessment.

QA/testing was done at the start of the SDLC process.

Reviewing Corrective Action and Preventive Action (CAPA) documents was one of my responsibilities.

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