Samatha Perumalla

508-***-**** ad0mw5@r.postjobfree.com

Profile

QMS Manager & Senior Software Validation Engineer with 15+ years of professional experience performing validation procedures according to the regulatory guidelines and 21CFR part 11. Excellent verbal, written, communication, presentation, and analytical skills; detail oriented. Valued team player who makes every effort to work out issues/problems between development and quality teams in an effective manner, fostering a positive work environment. As an SME, serve as key point of contact for NPSS process in business, iServer inventory as a PQMS manager, Deployment of the standard process, create a business use validation acceptance form for the business on Philips Integrated Landscape applications and business analysts on issues in complex design of templates for test cases or test scripts for client standard specifications.

Highlights include:

Create system design and process risk analysis documents and Document Change Control Plans.

Proficient in quality documentation skills, including Quality Transition Plan, Impact Assessment, Business Use Validation Acceptance form in compliance with regulations,

Write, review, and revise software standard operating procedures (SOPs) and user manuals.

Develop, implement and manage key performance indicators (KPIs) for the PD Business in inventory tool management of iServer, including providing training to the team.

Involved in Project Management activities of an application.

Proficient in validation documentation skills, including Quality System Impact Assessment, Risk Assessment, Validation Plans, User Requirement Specification (URS), Functional Requirement Specification (FRS), Design Specifications (DS), Validation protocols (IQ/OQ/PQ), Summary Reports (IQ/OQ/PQ/Validation) and Periodic Review Report in compliance with GxP.

Proficient in validating IT Systems (Agile, TEDS, IC Coils Trending report, Synapse, and Clinphone 4 to name a few).

Write test plans, test scripts or test cases, and test reports.

Develop Requirements Traceability Matrix (RTM) and technical standard documents.

Expert in inventory release management of CLARA/SAM, including providing training to the team.

Experience in VXML.

Use Selenium webdriver and ValGenesis automation tool to run the automated scripts.

Technical Skills

Validation: 21 CFR Part 11, 50, 54, 58, 210/211, 312, 314, 820, cGxP (cGMP, cGLP, cGCP), GAMP5, URS, FRS, RTM, IQ, OQ, PQ, SOP, VSRs, PRR, BUV Acceptance Form.

Quality Documents: Quality Transition Plan, Impact Assessment, Change Plan, Inter-Company Quality Agreement (ICQA), Business Use Validation Acceptance

Operating Systems: Windows 98/NT/2000/XP, HP-UNIX, and MS-DOS.

Databases: Oracle 9i/8.0/7.x, MS Access, VXML, SAP and SQL Server.

Languages: C, C++, SQL, Java.

Packages and GUI: ARIS, Adobe Sign, iServer, Business Objects, Qlik Sense, WindChill, MS Office, MS Visio, MS Power Apps

Professional Experience

PHILIPS, Cambridge, MA 2017 – Current

QMS (Quality Management System) Software Validation Engineer / QMS Manager

Support the Transition of an application from one Quality Management System to another with a proper documentation.

Implement Quality Transition Plan and Impact Assessment for the Doc Control process deployment and implement the Business Use Validation acceptance form for the Philips Integrated Landscape (PIL) tools (Windchill DRM and Adobe Sign).

Ensure compliant and effective QMS for the activities in scope, as well as for effective and lean QMS structures and documents for Q&R processes.

Establishes the PQMS and manages its deployment

Maintain proper audit planning and schedule meets the requirements of internal policies and external regulations.

Train peers in all aspects of the quality system and NPSS /Doc Control /QMS procedures.

Ensure all necessary validation documents and procedures are in place to satisfy all customer requirements and audits.

Involve and implement in the deployment of the NPSS process of the Quality Management System.

Involved and support in the QMS Consolidation activities.

Implement Quality Transition Plan and Impact Assessment for the NPSS process deployment and implement the Business Use Validation acceptance form for the Philips Integrated Landscape (PIL) tools (ValGenesis).

Manage and provide a detailed analysis of the nonconformities.

Ascertain and support the stakeholders with the process deployment of NPSS and CSV activities

Involved and support the application validation with Project Management activities.

Extensive working knowledge of Software Validation Lifecycle Methodology.

Lead and support team members with the Non-Product System Software (NPSS) and Computer System Validation (CSV) process.

Participated in Elicitation, analysis, decommission, acceptance, compliance, author, review, approval, the periodic review report, specification, and validation for intended use as an independent stakeholder.

Assist project teams in creating validation documents, including participating in developing application requirements, impact assessments, and risk assessments.

Traceability from the requirement to test and identify the gaps in test coverage.

Resolve, review, and update the quality data in the iServer tool as a PQMS Manager. Support and Maintain the Key Performance Indicators reports. Continuous monitoring and documenting of quality as well as communication to stakeholders.

Take ownership of the team cohesion and Focused target driven with a positive attitude.

Support the training activities in the TEDs learning system.

Generate the scheduled reports from the Business Objects application.

Key Accomplishments:

Achieved as a go-to person for NPSS and iServer knowledge, process, tools across various PD Business.

Knowledge transfer to the team on NPSS process, Quality Document Deployment methodology, iServer Inventory Management.

Clearer understanding of the ARIS and the impact on software validation.

PAREXEL, Billerica, MA 2005 – December 30, 2016

Senior Software BA/Validation Engineer

Responsible for validation of the following applications:

ClinPhone 4 (2015 – 2016)

ClinPhone is a system developed by ex-ClinIntel group that includes tools that are required to build, maintain, and support clinical studies through interactive voice response systems and interactive web response systems. ClinPhone 4 includes modules like PM tools (variables, design, tasks, IRT) and other modules. ClinPhone IVR/IWR/VXML solutions provide essential real-time randomization, emergency code-break, medication dispensing at site, and depot supply inventory control.

Key Responsibilities:

Mentored and lead team members.

Participated in Elicitation, analysis, decomposition, acceptance, approval, specification, and validation of the requirements.

Involved in Traceability and Monitoring of requirements. Continuous monitoring and documenting of requirements as well as communication to stakeholders.

Evaluated how well the solution fulfills the requirements and meets the business need

Authored operations testing plans and operations tests results for various modules, such as site activation, site management, and patient enrollment.

Assisted in the creation/maintenance of standard operating procedures.

Developed test strategies, following relevant SOPs to support specific project validation efforts as well as test scripts and summary documentation.

Wrote SQL queries to test whether data was updated correctly following the execution of test scenarios.

Extensive working knowledge on Unified Process Development Methodology.

Used JIRA in Agile process for tracking status of work in various clinical trials.

Automate manual test scripts using the Selenium web driver for quicker and consistent testing.

SYNAPSE (2008 – 2016)

Synapse is a system developed by ex-ClinPhone group that includes tools that are required to build, maintain, and support clinical studies through interactive voice response systems and interactive web response systems. SYNAPSE includes modules like Cons Manager, Data Editor, Event Viewer, Gateway Manager, Migration Tool, Schedule Manager, Security Manager, Visual SDL, and other modules. SYNAPSE IVR/IWR/VXML solutions provide essential real-time randomization, emergency code-break, medication dispensing at site, and depot supply inventory control.

Key Responsibilities:

Conducted gap analysis between application and stated customer requirements and collaborate with Architects and Developers to estimate project impact.

Delivered precise functional specifications to include functional hierarchy, workflow, business rules, interface design and definitions, outstanding issues, data analysis, and data mapping to clients and development staff.

Mentored and guided junior resources

Been responsible for direct interaction with clients including, but not limited to, eliciting comprehensive business requirements and use cases, providing value-added analysis, and recommending appropriate solutions

Gather requirements and help build and document specifications for development.

Updated and maintained Requirements Documentation, Requirements Traceability Matrix, and other project documentation

Served as Test Lead to work with team members involved with software validation management, quality process management, application development/engineering, and project management to ensure quality standards were met.

Authored validation plans and validation test results for IVRS/IWRS systems for different clients.

Contributed to the creation of project requirement specifications for clinical studies.

Developed and executed detailed test specifications and tracked detailed results.

Monitored and maintained automated software defect tracking database using Bug Zero.

Utilized Selenium Automation Tool used for site management modules.

ALADDIN™ (2005 – 2008)

ALADDIN™ is a software application developed by Perceptive Informatics, Inc. that is used to develop/run interactive voice response systems and interactive web response systems. The tool facilitates building critical clinical trial functions, like patient enrollment, randomization, and patient diary collection. ALADDIN™ is a flexible, user-friendly, and robust tool for IVRS creation and facilitates automated inventory solutions and automatic faxing and email.

Key Responsibilities:

Reviewed requirement specifications and suggested necessary updates to the requirements for a number of clinical studies.

Validated IVRS/IWRS for a number of clinical trials and various clients, like Astra Zeneca, Cardiokine Biopharma LLC, Astion, Forest Laboratories, Wyeth Pharmaceuticals, Roche Pharmaceuticals, Aveo Pharma, Renovo, Novartis, Pfizer, Sanofi Aventis, and PhotoThera.

Wrote, reviewed, and executed test scripts for various complex functionalities, like inventory management, randomization, and data transfers.

Used LiveLink system for document authoring, reviewing, and approvals.

Prepared software impact assessment documents for change requests. Wrote, reviewed, and executed test scenarios for validating CRs.

Supervised new team’s work, reviewed the written and executed test scripts, and coordinated between teams.

Key Accomplishments:

Achieved a record of zero defects in most of the clinical trials.

Recognized multiple times in Parexel recognition programs.

Trained a team of newly hired validation engineers on GCP, 21 CFR Part 11, SOPs, Randomization, Inventory Management, and ALADDIN™.

Education

Master’s Degree, Mathematics, Kakatiya University, Warangal, India

Bachelor of Science, Kakatiya University, Khammam, India

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