Karthik B

Phone: 973-***-****

Email:ac6e3c@r.postjobfree.com

PROFESSIONAL SUMMARY:

Overall 7 years of experience as Business analyst and extensive experience in Computer System Validation in compliance with FDA standards.

Good knowledge of Software Development Life Cycle (SDLC), familiar with Software Methodologies like Waterfall, V-Model and Agile in relation to development and testing.

Hands-on experience with GAMP 5 Guideline, documenting project and validation deliverables, gathering business, functional and System requirements, developing testing and validation protocols (IQ/OQ/PQ), summarizing reports and final validation packages.

Superior knowledge of GAMP, GxP's (GCP, GLP and GMP), 21-CFR Part 11 regulation of Electronic Records, Electronic Signatures and Audit Trails.

Expertise in preparing and reviewing User Requirement Specifications (URS), Functional Requirement Specifications (FRS) and Design Specifications (DS) in compliance with applicable FDA rules and regulations.

Experienced in preparing and reviewing Test Plans, Validation protocols (Installation Qualification - IQ, Operational Qualification - OQ, Performance Qualification - PQ), Test Summary Report and Requirement Traceability Matrix (RTM).

Experience in reviewing all SDLC documents, protocols and SOP's to ensure they meet FDA regulations.

Experience in reviewing Corrective and Preventive Actions (CAPA) and highlighting and suggesting there mediation plans to mitigate the non-compliance.

Tracked and documented Change Requests using HP Quality Centre and ALM.

Experience working with Track wise to initiate and approve Validated System Change Requests (VSCR).

Skilled in developing Standard Operating Procedures (SOP's), policies and working instructions to comply with FDA regulations.

Experience in coordinating and facilitating delivery of project objectives.

Completely exposure to all companies GXP Learning Management Systems requirements.

Experienced knowledge in quality related regulations and FDA, ICH and EU guidelines.

Aptitude in System testing performed manual testing and automated testing. Proficient with Excel to manage different testing and data segregation activities.

Exposure to GXP audits activities especially in onsite environment.

Experienced in QMS system, electronic document management system and performed vendor assessment reports.

Experienced in monitoring and tracking the system for any Change Controls, Product Complaints, Deviations and CAPAs for root cause analysis and also support the Quality organization environment.

Developed and generated reports based on GCP guidelines.

Participated in early stage of SDLC through QA/Testers team.

Understanding of QA processes, practices and systems.

Experienced in SAS clinical data migration and supported the data cleaning activities.

Supported Quality Assurance (QA) activities related to complex applications and system implementation projects.

Participated in executing QA roadmaps and strategies.

Expertise in the area of Software Quality Assurance, including system analysis, systems design, documentation, implementation and integration of project management systems on various platforms

Excellent communication and interpersonal skills along with strong ability and flexibility to perform both individually and also as a part of team.

TECHNICAL 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, and V-model

Applications

SAGE ERP MAS 200, Track wise QMS, DMS, SAP ERP,QMS, SAS Base programming.

Operating Systems & Server’s

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

Database

MS SQL Server

Testing and Tracking tools

HP ALM, Track wise, Service Now, Jira.

EDUCATION

Bachelors in pharmacy Rajiv Gandhi university of health sciences, India

Master’s in Pharmacology, University of Bedfordshire, UK.

PROFESSIONAL EXPERIENCE:

HILL-ROM CO INC

Project: Retrospective validation of SAGE ERP MAS 200 Feb 18 – Till date

Role: Quality Assurance/Validation Analyst

Client: Trumpf Medicals Charleston.

Responsibilities:

Completed all training documents for GCP and 21 CFR Part 11 through Learning Management System.

Writing Validation Plan, Risk Assessment, Quality Assurance review, Validation Summary Report in compliance with 21 CFR Part 11 and GxP FDA Compliance Regulations.

Writing requirements for SAGE ERP MAS 200 through meetings with business Owners and subject matter experts, writing Requirements, Test Plans, and Test Cases using HP ALM.

Was responsible for reviewing Installation Qualification (IQ)/Operational Qualification (OQ)/Performance Qualification (PQ) test scripts.

Involved in version control of end user Spread sheet application through change management process.

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

Developing test cases/scripts (IQ, OQ) for verification against specifications to ensure fitness for intended use of the Spread sheets.

Managing the Spread sheets under Change Control process to document, rectify any deviations and handle version control efficiently.

Coordinated UAT (User Acceptance Testing) for the application.

Reviewed the Requirement Traceability Matrix (RTM).

Was involved in reviewing Test Cases, Test Scripts and Test Summary Reports.

Worked on Risk Assessment of the systems.

Performed QA/testing at the initial stage of SDLC process.

Was involved in reviewing Corrective Action and Preventive Action (CAPA) documentation.

Developed Test Cases for Functional and Regression Testing and analyse bugs and defects and identified ways to improve overall product and process quality.

Reviewed protocols for Audit Trail, time stamp and electronic signature for workflow of documents.

Reviewed existing Standard Operating Procedures (SOP’s) for System Administration.

Performed daily monitoring and identifying the defects in QC environment.

Worked on daily tracking and monitoring QMS for any change control requests and initiated CAPA when required.

Identifying the root cause analysis for software defects.

Worked on gap analysis for QMS and daily tasks for scheduling the activities related to support data migration.

Provided end to end support for maintaining and reviewing of records and archiving based on security scheduler.

Performed Tracking and generated reports based on QA metrics.

Collaborated with QA manager and QA team to develop, implement and improve innovative QA capabilities, approaches and services.

Project: Application: Track wise QMS May 16 – Jan 18

Role: Validation analyst

Client: Protide pharmaceuticals, Lake Zurich, Illinois, IL

Responsibilities:

Participated in meetings with end users to understand Business Process Analysis (BPA) and Business Process Risk Assessment (BPRA) and validation of Global Track wise as per change control.

Gather requirements information needed for business processes during the inception phase, documented and delivered functional specification documents and assisted in architecture analysis and design the UML.

Prioritized testing activities revolving around the web portal after collaborating with the QA and UAT teams, Solution Architect and Developers for SIT and UAT.

Perform manual testing, system, regression, integration, front-end testing in Agile Scrum environment.

Made recommendations to portfolio managers concerning equity selection and derivative trading.

Educate clients about a variety of topics including options, futures contracts, retirement planning, fixed income products, and variable annuities.

Validated Track Wise QMS tool and was involved in doing Functional Risk Assessment.

Validated custom workflows such as Sample Process Workflow and Template Process Workflow.

Reviewed the Vendor Assessment Reports and developed URS and FRS drafts based SOP blue prints.

Involved in reviewing documentation of the computer system validation lifecycle and other documents in accordance with FDA regulations of RIR and SMS (Safety Management System).

Making sure every team following the Standard operating procedures and templates for the preparations of entire documents.

Reviewed documents of URS, FRS and DS in accordance with FDA regulations, particularly 21 CFR Part 11 and GxP regulations.

Reviewed and approved compliance plan, compliance analysis, Requirement specifications and Design specifications for the both systems.

Reviewed RTM for the both systems and also did Stage Gate Assessment for those systems.

Involved in developing Testing protocols and also Configuration control doc and security control doc.

Involved in reviewing the Data conversion and data migration document for the system.

Reviewed Test plans, test scripts, for IQ protocols, Systems testing and UAT based on requirements of the application.

Reviewed Traceability Matrix to keep track of relationship between Requirements specifications and Test Scripts.

Project: Application: SAP ECC, Jan’15–Apr’16

Role: Business analyst

Client: Day and Zimmerman-Philadelphia, PA

Responsibilities:

Involved in preparing documentation of the computer system validation lifecycle, in accordance with FDA regulations.

Conducts and facilitates JAD sessions to develop and coordinate the requirements, specifications, design, and testing efforts for medium to large projects

Analyzes business workflow and system needs for conversions and migrations; assists in data mapping

Defines and develops test plan documentation to support system validation and/or User Acceptance Testing

Conducts gap analysis and uses analytical skills to identify root cause and assist with problem management.

Create Issue log to keep track of issues and work with QA team to come up with resolutions.

Develops business processes that ensure developed application meets all project requirements, ensures that projects are completed on time, accurate to defined specifications and within budget

Translates business and IT requirements by reviewing, analyzing and evaluating needs into functional specifications.

Supports or leads the process of screening, framing and modeling ideas for process improvements or cost savings.

Interacted with system developers to resolve questions and discrepancies in Business Requirement Documents

Involved in validation of SAP ECC and SAP Support Packs implementation and Web Applications in accordance with Company policies and procedures.

Involved in meetings with users to review and approve Business Process Procedure (BPP), User and Functional Requirement Specifications (URS & FRS).

Reviewed and approved Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).

Developed Validation Plan, Traceability Matrix, Master Test Plan, Validation Summary Report documents.

Executed test scripts in HP QC/ALM.

Created and Reviewed Test plans, test cases, for IQ, OQ, and PQ protocols based on requirements of the application.

Wrote Standard Operating Procedures (SOP's) for all aspects of the validation life cycle, in accordance with FDA regulations, particularly 21 CFR Part 11 and GxP regulations.

Developed Traceability Matrix to keep track of relationship between Requirements and Test Scripts.

Involved in Qualifying the Web applications, Client/Server applications according with 21 CFR part 11requirements like Security, Audit Trail etc.

Developed Validation Deliverables that are required by SDLC policy and FDA regulations.

Conducted assessments of regulated systems to assure validation procedures have been followed incompliance with company, divisional and departmental policies and predicated rules.

Involved in generation and implementation of QA and QC procedures and policies.

Involved in Gap Analysis, Risk Analysis and prepared Remediation plans.

Conducted Periodic Evaluation to demonstrate that system remains in a validated state in its life cycle.

Developed Validation Summary Report (VSR) to summarize all validation activities.

Project: Applications: Veeva vault, Feb'14 - Dec'15

Role: Validation Analyst

Client: Steep Hill Labs - Berkeley, CA

Responsibilities:

Coordinated product complaints through Veeva Vault. Initiated investigation and identification of root cause for defects returned from the field under FDA and GMP guidelines.

Completed all training documents for GCP and 21 CFR Part 11 through Learning Management System for VeevaVault cloud based application.

Monitored the databases and performed quality check of records and maintained records for non-risks complaints. Global quality system to manage CAPA, Deviation, Change Control and Audit Management workflows.

Involved in creating a Validation Strategy and Validation Plan to establish a Process to full fill the Validation Activities.

Validation activities are performed according to the GAMP V-Model and GAMP5 guidelines.

Involved in documenting Checklist and Assessment to ensure that the system is in compliance with 21 CFR Part 11requirements according to FDA Regulations.

Reviewed and Approved Process Workflows and Definition documents, User Requirements (URS), and Functional Requirements (FRS) documents.

Mentored the Testing Team on Good Documentation Practices. .

Workflows implemented included complaints, CAPA and Change Control.

Tracked IQs, OQs and PQs to ensure they are approved in time and they address the deviations correctly.

Involved in preparation of Validation Plan to Validation Summary Report.

Conducted Risk Assessment sessions to analyze the GxP, Business and functional impact on the user requirements with process owners, functional team and QA compliance.

Conducted routine internal inspections of regulated systems (GMP, GLP, and GCP) to assure validation procedures have been followed in compliance with company, divisional and department policies.

Involved in GAP analysis for user requirements verification and devised remediation plan.

Developed Standard Operating Procedures (SOP's) and ensure compliance with FDA regulations.

Worked with different work streams to finalize the Test Strategy and qualification plan.

Review and execute test cases in Quality Center, managed defects and resolution activities.

Developed Validation Summary Report to summarize all the validation activities.

Extensively used Enterprise Data Management platform Documentation for maintaining validation life cycle documents.

Project: Applications: EDMS/ERP, Blue bell, Nov'11- Dec’13

Role: Quality Assurance analyst/Validation Analyst

Client: Hospira INC, Lake Forest, IL

Responsibilities:

Participated in Validation Life Cycle (VLC) planning, implementation and documentation. Wrote documentation for all aspect of the computer systems validation lifecycle, in accordance with FDA regulations, particularly 21CFR Part 11.

Maintained all the logs and documents through a document management system Documentation.

Followed the Standard Operating Procedure SOP's for Document management system.

Utilized Documentum for storage and retrieval of documents.

Responsible for storing and maintaining the documents to comply with 21 CFR Part 11 requirements.

Involved in documenting Validation Plan, Validation Protocol, Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ) Specifications.

Documented URS (User Requirement Specification), FRS (Functional Requirement Specification) based on BPRS (Business Process Requirements).

Involved in writing the Risk Assessment documents, Test Summary Documents and Validation Summary Report (VSR) to summarize overall validation activities and to establish documented evidence that the system was validated according to the standards of 21 CFR Part 11.

Asserted validation documentation for complying with CGMP sensitive transactions.

Maintained the Requirement Traceability Matrix (RTM) to gauge the progress on a regular basis.

Developed test plans, test strategies, test scripts for validation testing along with the Test Summary Report.

Performed integration and regression testing to ensure software is not adversely affected and validate existing functionality.

Executed SQL queries for back-end analysis and testing of data.

Tracked product defects found during validation testing and report issue status and quality metrics.

Verified and resolved defects in each release and performed manual testing.

Involved in reviewing Corrective Action and Preventive Action (CAPA) and drafting Remediation plans for the project management approval after GAP analysis.

Executed test cases based on the test plan and in accordance with Good Documentation Practices (GDP).

Developed and documented Test Plan and Test Cases using specifications from the business Requirements.

Developed a road map by analyzing the Business Requirements for manual testing that included test objectives, test plans and test cases development.

Responsible for writing Validation Summary Report.

Performed critical reviews of batch records, testing results and engineering documents reported to Quality Assurance manager.

Reviewed and investigate deviations, excursions and CAPAs.

Provided excellent product free defects to end customers based on our Quality Assurance environment.

Environment: EDMS and SAS.

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