JYOTHI GADDAM

Email: ad0s9e@r.postjobfree.com

Cell: 732-***-****

OBJECTIVE

Seeking a challenging position to further my technical experience while developing my leadership skills and utilizing my communication abilities to achieve individual and team-based organizational goals

TECHNICAL SUMMARY

●Over 7 years of experience in Pharmaceutical Industry with 21 CFR Part 11 compliant validation and change control management of Business Applications.

●Experience in authoring and reviewing of validation deliverables such as validation plan, data migration plan, test plan (SIT, UAT), promotional forms (quality and production environments) and summary reports.

●Strong knowledge and background of software development life cycle (SDLC)

●Extensive experience in executing of IQ/OQ/PQ test cases in a GXP environment.

●Experience in reviewing and approving requirements, test scripts (pre and post) and defects in ALM (Vera Template)

●Experience in performing Gap Analysis, Root Cause Analysis, Corrective and Preventive Actions (CAPA) Reporting.

●Excellent knowledge and experience in Good Documentation Practices (GDP).

●Experience in Validation of SAP S/4 HANA Planning, Procurement, Quality Management, Order to Cash, Inventory Management, Master Data Governance, Controlling, Finance and Security.

●Experience in Validation of SAP SuccessFactors Learning Management System (LMS), Employee Central (EC), Recruiting, On-boarding and Compensation Management.

●Working knowledge of Cloud based software-as-a-service (SaaS) arrangements.

●Have Knowledge on key Pharma Application like TrackWise and Documentum.

●Proven ability to work efficiently in both individual and team based environments.

●Innovative thinking and strong problem solving skills.

●Excellent communication and organizing skills with the ability to grasp and learn new things quickly.

SKILLS

Computer System Validation ~ Solution Manager ~ VeevaVault ~ TrackWise ~ Agile ~ Waterfall ~ SDLC ~ ALM (Vera Template) ~ ServiceNow

EDUCATION

MSIT Southern New Hampshire University, NH 2016

B-TECH, JNTU, Hyderabad, India, 2014

PROJECT DETAILS:

Astellas, North Brook, IL.

Validation Specialist (Apr 2021 – Present)

Astellas Manufacturing has been at the forefront of regulatory compliance and brand support for the pharmaceutical and life sciences industries to manufacture the Stirile drugs.

Project: The project involved authoring, routing and tracking documents in compliance with 21 CFR Part 11 for Incident Management Project

Responsibilities:

●Involved in preparing Validation plan, data migration plan, test plan (SIT, UAT), promotional forms (quality and production environments) and summary reports.

●Developed Installation guides and Release Notes for the Released Application

●Mapped features between legacy systems to SuccessFactors on cloud system

●Managed implementation partner, client, and third party resources in design, build, and validation phases to deliver required Success Factors functional capabilities within client defined time frames

●Responsible for Success Factors system admin functions including user admin/security, role based permissions, user notifications, route maps, template/form attributes, etc across Performance, Recruiting, Employee Central, On boarding modules.

●Experience in Validation of SAP S/4 HANA Planning, Procurement, Quality Management, Order to Cash, Inventory Management, Master Data Governance, Controlling, Finance and Security.

●Conducted Software/documentation usability tests

●Performed and implemented technical and peer reviews of product documentation

●Coordinates, assigns, tracks, and assesses multiple documentation projects

●Was involved in documentation during various stages of the validation lifecycle, in accordance with FDA regulations, including 21CFR Part 11.

●Provides status updates on projects as required by management

●Worked closely with users and the vendor to understand and document user requirements, and functional design specifications.

●Developed and implemented validation and quality assurance programs including Standard Operating Procedure (SOPs) governing validation activities; templates for validation related documentation such as validation protocol and plans, Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ)

●Provided QA oversight to the developers and facilitated the development and implementation to meet the requirements of 21CFR Part 11.

●Used HP Application Lifecycle Management (HP ALM) to execute Test Scripts, perform pre-execution and post-execution approvals before sending to Quality Assurance department.

●Reviewed the test scripts and 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.

●Analyze regional quality data (exports from Trackwise, SharePoint, and Access DB) for trends and potential areas of improvement.

●Involved in updating the Testing Methodology for the QA department and generating various documents to provide uniformity in the execution and reporting of tests.

●Participated in documentation of the Validation Summary Report.

●Actively participated in Project meeting and reviews.

QPharma Inc., Morristown, NJ Validation Specialist (Jan 2018 – Mar 2021)

QPharma, Inc. has been at the forefront of regulatory compliance and brand support for the pharmaceutical, medical device, and other life sciences industries.

Client: Merck

Project: I worked in the implementation of GxP systems (Cloud based and Inhouse). I validated iStabilty LIMS, SuccessFactors Learning Management System (LMS), TransPerfect Electronic Trial Master File (eTMF), CIRRUS Electronic Document Management System (EDMS) systems.

Responsibilities:

●Authored Periodic Review Reports for the cloud based systems liks SuccessFactors Learning Management System (LMS) and CIRRUS EDMS.

●Created Controlled Document Change Request (CDCR) forms for validation deliverables.

●Authored IT Change Control Request (CCR) forms.

●Assisted in System Risk Assessment, deviations and CAPA and other validation delivarables

●Conducted GAP analysis for User Requirements verification in compliance with 21 CFR PART 11 and formulated Remediation Planning to avoid project deviations

●Documented all aspects of computer systems life cycle (SDLC) in accordance with FDA Compliance for automated systems.

●Experience of Labelling systems like Esko, Web Center and Bonitasoft BPM.

●Modified Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) for instruments like Spectrophotometer, Chromatography (HPLC & GC).

●Updated the Traceability Matrix and Configuration Specification for EDMS, LMS, eTMF systems.

●Responsible for ensuring the compliance of GMP/GLP and FDA regulations

●Conducted Gap Analysis for reporting purposes which helped in ascertaining the true milestones for the project

●Analyzed User and Functional requirements to perform gap analysis between critical functions of the manufacturing processes against predetermined processes design.

●Writing and executing protocols and reports for all elements of Software Validation (User and Functional Requirements, Risk Assessment, IQ, OQ, PQ and configuration management).

●Performed Risk Assessment and issued CAPAs.

●Conducted Vendor audits and prepared initial and final vendor audit reports.

Bio-Rad Laboratories, Inc., Hercules, CA

Validation Analyst (Apr 2016 – Nov 2017)

Bio-Rad Laboratories, Inc. develops, manufactures, and markets a broad range of products for the life science research and clinical diagnostics markets

Project1: The project was implementation of Electronic Document Management System tool Documentum in organization communication with CFR part 11 compliance. I was involved in leading risk analysis, mitigation, collecting user requirements, functional requirements, authoring test scripts, and system validation.

Project2: The project was collecting user requirement, functional requirement, writing test scripts, validation, and gap analysis of LMS application tool eLearning. Decommissioning LMS legacy system: Kaplan. Modules tested are training workflow (e.g., user notification, manager approval, wait-list management), the provision of on-line learning (e.g., computer-based training, read & understand), on-line assessment, management of continuous professional education (CPE), collaborative learning (e.g., application sharing, discussion threads), and training resource management (e.g., Instructors, Facilities, equipment) for clinical and non-clinical staff training compliance for the organizational and FDA clinical trial compliance.

Responsibilities:

●Contributed in Project management plan and controlled progressive elaboration.

●Implemented Delphi method to get the consensus with users, quality and designers.

●Performed as Analyst in validation and authored software validation records like validation plan, Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualification (PQ) and ensured quality and compliance of the deliverables.

●Created Requirement Traceability Matrix (RTM), validated system design against requirements, and effectively worked with Quality Assurance (QA) teams on completing User Acceptance Testing (UAT).

●Gathered requirements and conducted requirements review meetings with LMS core team, project team, sub teams and business representatives, software vendors.

●Implemented projects under GAMP 5, GCP and GLP environment.

●Maintained project documents, action items, decisions, risks and electronic library using MS SharePoint 2010.

●Co-ordinated with Developers, QC lab managers, LMS core team, Project manager to develop AS-IS and To-Be workflows

●Using Igrafx and MS Visio for various lab processes such as Sample management, Plate management, Instrument & reagents management etc.

●Participated in Vendor Audit: Issuing Audit report, Notification Letters, CAPAs, Gathering Responses and Finding, and finalizing Audit Reports.

●Gathered and developed User and Functional Requirements Specification (UFRS) for various systems, namely: Quality Analysis and Auditing Database (QAAD), Unified Change Control (UCC), Clinical Data Management System (CDMS), Electronic Data Management System (eDMS), Laboratory Information Management System (LIMS), Learning Management System (LMS) and various clinical / non-clinical systems / application / databases

●Assisted in review and revision of Standard Operating Procedures (SOP) s for the change control.

●Assisted the project manager to review & address action items, in process and Upcoming action items, Change Control Requests (CCR), Project Plan, Risks, Billing & Budget, Timeline, Documentation, resource availability.

●Managed the project plan using MS project Gantt chart and WBS for decommissioning of legacy system and project management.

●Authored, executed and reviewed test requirements, test plans, test scenarios, test cases & test scripts based on the Use Case documents, business requirements, risk assessment document and design document.

●Conducted risk assessments to identify possible risks and created mitigation plans, gap analysis to identify potential gaps in procedures and business processes and quality assurance reviews to evaluate compliance with requirements.

●Implemented change management procedures and managed deployment project, performed schedule management solely with minimal supervision to around 12 departments, which involved more than 1500 employees and aided for on-time project completion.

●Prepared and presented the information by performing data analysis using MS Excel 2010 on regular basis to support decisions on project execution and technical performance metrics.

Cardinal Health, Miami, FL

Validation Consultant (Apr 2014 – Mar 2016) Cardinal Health, Inc. is a Fortune Global 500 health care services company specializes in distribution of pharmaceuticals and medical products, serving more than 100,000 locations. The company also manufactures medical and surgical products, including gloves, surgical apparel and fluid management products.

Project: The project was mainly focused on Validation of various Monitoring Systems that are used for providing important patient parameters during a cardiac surgery.

Responsibilities:

●Worked in concurrence with FDA 21 CFR Part 820 regulations for the entire project.

●Developed the list of medical devices and classified for premarket submission.

●Gathered User Requirements, Functional Requirements and generated Conformance Standard Documents.

●Responsible for determining the System Risk Assessment (SRA) and Functional Risk Assessment (FRA) for the devices and systems under part 11 regulations.

●Prepared Validation Master Plan (VMP) for validating the systems.

●Conducted meetings with the system users to gather User Requirements.

●Participated in updating the Requirement Traceability Matrix.

●Developed and executed the Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) test scripts for the new functionalities.

●Involved in documenting and executing Test plan, Test cases and Test scripts.

●Participated as a team member to draft a Remediation Plan for Project Management approval after Gap Analysis.

●Prepared Validation Summary Reports and Standard Operating Procedures for Monitoring Systems.

●Provided input and feedback to the Quality Assurance team in the execution of the test plans and test cases.

●Reviewed Change Control documentation for the medical systems related work instructions for quality and compliance issues.

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