RAMYA MANGENA

· Responsible for creating new records, editing existing records, and submitting records for approval.

· Involved in creating new records for Software change request, User requirements, Software Compliance report, Project Validation plan, E-records and E-signature Risk assessment, Test design steps, Traceability matrix and System certification summary.

· Involved in creating Cybersecurity Risk management, participating in working sessions with Business process owners and completing the DIV08552 Cybersecurity assessment with DIV08498 Flowpath and routing it to CFT approval.

· Generated and extracted the traceability matrix from VERA into Excel with ALM configuration tool.

· Authorized to review records and approve them with an electronic signature.

· Responsible for creating new design steps as per business requirement and routed test plan for approval.

· Managed and executed the test process, analyzed system requirements specifications and developed appropriate test plans and test cases. Executed test cases and verified actual results with expected results.

· Involved in completing periodic review coordinating with Document control group and SME.

· Initiated the package for periodic review and routed the package for CFT approval in epas.

· As an SQA involved in both content originating and approving Protocols, Test runs and User requirements.

· Participated and supervised Cybersecurity working sessions for various systems such as GLP Track stimulator, SEMAS, WWLIMS, VERA, APLM.

· Completed Risk and gap assessments for various systems i.e. AFMS, CIP, Cary60, CMSNext, EDMS, Empower5.1, GS1-MT and Prism_Metrics.

• Authored Installation Qualification, Operational Qualification and Operational Qualification protocols for Lab Instruments
• Developed and Executed Validation life cycle deliverables which include validation plans, requirement specifications, Risk Assessments, test plans, (IQ, OQ, PQ) protocols, Traceability Matrix, and validation reports for Lab Equipment's in compliance with GXPs and FDA guideline
• Executed validations and documents validation results in final reports (IQ Report)
• Executed, final Report (IQ Report) and other Validation Deliverables preparations (URS, FRS
• Trace, etc.)
• Authored operational, maintenance and calibration procedures for production equipment, test equipment, and utilities
• Knowledge in the informatics tools\ processes like LIMS, SDMS, Track wise, CDS, CSV, SAP, MES
• Performed risk management activities using Failure Mode Effect Analysis (FMEA) techniques to identify potential failure modes on pharmaceutical and medical device manufacturing equipment
• Development of reports and dashboards in Power BI based on research and analysis of Market/Sales data from various healthcare business segments over multiple demographic levels
• Developed Power BI reports for Management Metrics for Diagnostics, and Core Labs
• Performed Data integrity Assessments and Remediation plans for Digital Gauge, Kaye validators, Prism instruments and Standalone, Instron, etc
• Responsible for creating Traceability Matrix, which provides the trace of Functional Requirements and electronic records and electronic signatures requirements
• Collaborate with Validation Lead to create Validation Reports and Summary reports which includes Testing Strategies, Defects if any, Final approvers, SQA comments and other important observations as part of the test execution
• Evaluate User Requirements Specifications and the corresponding Functional Requirements Specifications and work with various project/business stakeholders to understand system related functionalities and involve during User Acceptance Testing
• Interact with Project Sponsors, Owners, Project Team Members, Vendors, and Subject Matter Experts to understand the business problem that needs to be solved
• Perform Training of different systems in the ISO-Train, a Learning Management system, owing to Abbott resource training policies and procedures.

• Experience in writing regulatory documents such as CSRs (Clinical study reports), IBs (investigator brochures), Protocols, informed consent forms according to the ICH-GCP guidelines
• Involved in preparing compliance report about existing status of the cGMP, GCP and GLP
• Authored Installation Qualification, Operational Qualification and Operational Qualification protocols for Lab Instruments
• Involved in Visual inspection (Syringe inspection equipment, Validation Protocols and Equipment tools.)
• Served as a Regulatory representative in project teams and provided regulatory support (strategy) for new products/therapies and modifications to existing products
• Tracked and maintained all regulatory deficiency correspondences and maintained the tracking of global regulatory requirements
• Incorporates required regulatory standards (FDA, ISO) in developmental and/or sustaining engineering projects including written protocols, test methods, assembly processes and the design history file
• Studying the Capability and Performance of the equipment by analyzing the data and making appropriate corrective actions
• Developed and Executed Validation life cycle deliverables which include validation plans, requirement specifications, Risk Assessments, test plans, (IQ, OQ, PQ) protocols, Traceability Matrix, and validation reports for Lab Equipment's in compliance with GxP and FDA guideline
• Act as Subject Matter Expert (SME) for Clean Utility Systems such as: Water for Injection, Clean Steam, Purified Water, Compressed Air for Processes, and Clean Gases
• Involved in Factory Acceptance testing (FAT), and Site Acceptance Testing (SAT) of Lab Equipment related systems as required by the company
• Possess knowledge on food, drug and medical device law
• Strong knowledge of Microsoft Office Suite as well as statistical software packages (Minitab)
• Drafted, prepared, and documented software validation protocols (IQ, OQ and PQ) for integration of LIMS
• Experience with troubleshooting the technical SW and physical equipment issues
• Performed GAP Analysis to verify the requirements matches with the functionality and developed remediation plans
• Implemented Root Cause Analysis (RCA) on deviations and successfully resolved and documented the deviations with actions taken following FDA regulations using Good Documentation Practices
• Performed audits for existing validation activities and conducted pre-approval inspections to identify the deficiencies in quality systems
• Design, develop, implement, and test embedded software in support of various spacecraft payloads being developed, including GNC and robotic systems
• Strong background in Commissioning, Qualification, Validations and Quality
• Knowledge in FDA, GMP's, GAMP5, GxPs, Automation, CSV, MES, ERP, Lab equipment, PLC, and Kaye Validator
• Preformed risk assessment using FMEA tool and recommended the actions depending upon severity to reduce the overall risk of failure from operational point of view
• Responsible for the qualification of the following equipment: tanks, bio-reactors, fermenters, autoclaves, lyophilizes, centrifuges, heat exchangers, pumps, biosafety cabinets, laminar flow hoods, glass washers, refrigerators and freezers, chromatography systems, aseptic filling units and incubators
• Working knowledge with the users and vendors to develop/document the requirements as assigned
• Verified the validation activities and adequately recorded, documented, and carried out the qualification in accordance with the approved Master Validation Plan(VMPs) and Validation Protocols
• Reviewed upstream and downstream validation procedures
• Drafted SOPs for Validation Policies, Change Control Procedures, Systems Operation, and safety precautions to be taken for proper handling of instruments
• Supported cleaning validation studies by working with cross-functional teams including product development, quality control and internal data auditors
• Reviewed the Design History Files (DHF)
• Generated protocol memos and final validation summary report (VSR) to summarize testing results and conclusion.

• Partnered with Validation/Quality departments in documenting and implementing 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
• Conduct QA review of regulatory submission documents
• Designing and implementing Manufacturing Execution Systems (MES) solutions that integrate IT solutions for customers in the pharmaceutical industry, while following Good Automation Manufacturing Practices (GAMP) and guidelines from FDA 21CFR11
• Support and maintain Quality Assurance programs, policies, processes, procedures, and controls ensuring compliance with current Good Manufacturing Practices (cGMP) expectations and established agency requirements/guidelines
• Involved in preparing compliance report about existing status of the cGMP, GCP and GLP
• Interacted with representatives of domestic and international partners, subsidiaries, and international regulatory authorities to discuss regulatory issues and submission requirements
• Used Kaye validator and Data Logger to perform temperature mapping of controlled temperature units (CTU) such as Refrigerators, freezer, and cold room
• Verification and Validation of different functionalities of the Rockwell Automation new and existed drives in an R&D environment
• Experience in setting up and configuration of Test Management and Change Request tracking tools like HP Quality Center, HP ALM and JIRA
• Performed facility and utility qualification, which includes developing and executing the IQ/OQ/PQ for Purified Water System, Compressed Air Systems, Nitrogen System, HVAC System and Area Qualification
• Performed IQ, OQ, PQ of Tablet Press, Refrigerators, coolers, freezers, flow hoods, Capsule machine, GPCG, Granulator, Blenders, mixers
• HVAC, Packaging lines including Serialization, Mills, Air Compressor
• Performed complex data analysis; prepared reports complying with USFDA, GMP and internal regulations; and coordinated material, instrument, and process validations
• Performed risk analysis and validation testing, as well as conducting all necessary test reports for any design or process related changes
• Experienced in validation, development, change control and programming of process automation control systems
• Conceptually designed all controls and monitoring components for a PLC controlled building automation system
• Support and maintain the legacy FactoryTalk Rockwell automation system, PCS upgrades, periodic reviews, audit trail review, computerized system inventory list maintenance, data integrity assessments, risk assessments, among other activities
• Strong familiarity with ISO 13485 / 14971, and 21 CFR Part 820, 210, 211, 58 requirements and compliance, to cGMP, GMP, FDA regulations
• Involved in the validation of EDMS, GxP Assessment database, Change Management System
• Developed and Executed Validation life cycle deliverables which include validation plans, requirement specifications, Risk Assessments, test plans, (IQ, OQ, PQ) protocols, Traceability Matrix, and validation reports for HVAC system in compliance with GxP and FDA guideline
• Involved in Factory Acceptance testing, and Site Acceptance Testing for HVAC related systems as required by the company
• Identified the required data elements, developed test strategies, cases, data, approaches for requirements and worked with users/vendors
• Involved in test execution and test defect resolution
• Performed GAP Analysis to verify the requirements matches with the functionality and developed remediation plans
• Reviewed, identified, and remediated legacy CAPA's for problem investigation, risk assessment, root cause and action plan.