Quality Assurance Validation Engineer

Roopa Penugonda 516-***-**** ************@*****.***

* ***** ** ************ ********** in the capacity of Validation Engineer and Quality Assurance in the Pharmaceutical and Life Sciences Industries. Vast working experience in different document management systems like Veeva Vault, Asset Management, Electronic Document Management System (EDMS), SharePoint. Authored and Reviewed SDLC deliverables which include Compliance Analysis, Risk Assessment, Requirements Specifications. Authored and Reviewed test protocols, IQ, OQ, PQ and test summary report. Skilled in Periodic Reviews, Risk analysis, CAPAs and documenting Remediation Process. Working knowledge of SDLC approaches including Agile and Waterfall. Experienced in authoring and execution of equipment Qualification/ Validation, Cleaning Validation & Process Validation protocols, performed testing and complied validation reports. Primarily responsible for protocol execution of distinct types of basic processing equipment for the following: incubators, freezers, refrigerators, and assembly equipment. Experience

SR. VALIDATION ENGINEER

Takeda Pharmaceuticals Lexington, MA

OCT 2024 – PRESENT

• Create and support review of validation life cycle documents for Analytical Instrument Qualification and computerized systems.

• Experience in validation of analytical instrument systems (e.g. benchtop analytical Instruments – material testing, Microvu, Olympus, PCRs etc.)

• Consult clients on data integrity requirements in Analytical Instruments and perform verification of them in the system.

• Author validation life cycle documents such as Validation Master Plan, Validation Summary Report.

• Reviewed different SDLC deliverables like Requirement Traceability Matrix, System Design & Configuration Specification, Risk Assessment, URS, IQ, OQ.

• Hands on experience in working with VeeVault/Veeva Vault.

• Reviewed and Executed approved IQ, OQ protocols in GxP facility.

• Collaborate with global team in delivering validation project deliverables.

• Worked with IT team to draft change controls in Service Now. VALIDATION ENGINEER

Bristol Myers Squibb Warren, NJ

JUL 2022 – OCT 2024

• Conducted thorough analysis of user and system requirements, ensuring all compliance and regulatory needs in the SDLC process.

• Developed and executed IQ, OQ, PQ documents, UAT, FAT, SOPs, and Engineering Change Requests.

• Conducted equipment validation tests in laboratory settings to ensure compliance with GMP standards and regulatory requirements.

• Reviewed and evaluated validation data to ensure equipment performance met predetermined acceptance criteria.

• Ensured all SDLC activities follow industry regulations and standards such as FDA 21 CFR Part 11, and EU Annex 11, supporting regulatory inspections and audits.

• Performed validation scripts according to predefined protocols and documented results in compliance with regulatory requirements.

• Recorded and analysed test results obtained during equipment validation and qualification activities.

• Performed risk assessments and impact analysis to identify potential risks in the SDLC, implementing mitigation strategies to ensure product quality and regulatory compliance.

• Reviewed and updated validation policies and procedures in response to changes in regulatory guidelines or company practices.

• Developed validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls.

• Hands-on technical experience, CAPA management skills used with the team to develop and execute effective plans.

• Supported laboratory equipment/systems implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.

• Conducted gap analysis and risk assessments to find potential data integrity issues and implemented corrective actions.

• Successfully led cross-functional teams in a GMP manufacturing environment, ensuring alignment with quality standards and operational goals.

• Completed all calibration, qualification and validation documentation with accuracy, completeness, and compliance to BMS standards.

• Created and managed various documents including Requirement documents, Validation/Test Plans, Requirement Traceability Matrices, Change Requests, Impact assessment documents, and Test/Validation Summary Reports.

• Authored reports summarizing protocol executions and exception reports finding defects or issues during test execution.

QUALITY ASSURANCE/ VALIDATION ENGINEER

Molex Clinton, MA

AUG 2019 – JUN 2022

• Extensive direct experience in Commissioning and Qualification (URS, FAT, IQ, OQ & PQ) of custom-built equipment such as Incubators, Temperature Controlled Units including Refrigerators, Cold Rooms and Freezers, Incubators.

• Participated in internal and external audits, including FDA and ISO audits, providing validation-related documentation, and addressing audit findings, as necessary.

• Prepared IQ, OQ, and PQ protocols for new and modified manufacturing equipment, processes, systems, facilities, and Utilities.

• Evaluated quality matters through a risk-based approach, making data-driven decisions that improved product quality and compliance.

• Conducted thorough audits and inspections to find potential quality risks and implement corrective actions.

• Conducted thorough data integrity assessments to find and mitigate risks associated with electronic records and signatures.

• Developed and executed protocols for uses and facilities validation, ensuring proper air quality and temperature control in compliance with regulatory standards.

• Collaborated with cross-functional teams to design and implement robust quality assurance processes and procedures.

• Developed and supported dashboards and reports within Veeva Vault Quality, providing real-time visibility into quality metrics and performance for data-driven decision-making.

• Conducted investigations into deviations and non-conformities, using FDA root cause analysis techniques to find underlying issues and implementing CAPAs.

• Facilitated discussion to define system criticality according to FDA regulations and performed risk assessment to create Quality Assurance Plan and Data Migration Plan.

• Managed bug tracking cycle with daily release calls with developers and various members of team to discuss and resolve defects arose during the UAT (User Acceptance Testing) execution.

• Performed equipment installation and qualification activities for laboratory equipment, manufacturing, and packaging equipment/systems.

• Developed validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls.

• Authored reports summarizing protocol executions and exception reports finding defects or issues during test execution.

• Reviewed vendor documentation to ensure compliance with regulatory and client requirements. Education

MASTERS OF SCIENCE IN ENERGY MANAGEMENT

New York Institue of Technology Old Westbury, NY BACHELORS OF TECHNOLOGY IN MECHANICAL ENGINEERING

Aurora Engineering College Ghatkesar, TG

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