Keerthana Merugu

• Experience with Technical writing of user’s manuals, online help, customer release notes, operating procedures and work instructions, batch records, product specifications, document lifecycle management. 
• Laboratory experience including microbiological testing in sterility, microbial identification, and bioburden testing. 
• Extensive experience as a Technical Deviation Writer and Documentation Analyst.
• Well versed in documenting Test Scripts (IQ/OQ/PQ Test Scripts), Deviations and Change Controls
• Knowledge of GAMP, GxP’s (GCP, GLP and GMP), 21-CFR Part 11 regulation of Electronic Records, Electronic Signatures and Audit Trails. Very motivated to learn and further my knowledge of the Manufacturing Industry as well as expand my knowledge of Quality Control Inspection.
• Experience in Software Development Life Cycle (SDLC), familiar with Waterfall, Liquid Chromatography, V-shape model and agile model.
• Well-versed with Quality Management System Trackwise which is used for Change request Management, CAPA and other investigations. 

• Experience with Technical writing of user’s manuals, online help, customer release notes, operating procedures and work instructions, batch records, product specifications, document lifecycle management. 
• Laboratory experience including microbiological testing in sterility, microbial identification, and bioburden testing. 
• Extensive experience as a Technical Deviation Writer and Documentation Analyst.
• Well versed in documenting Test Scripts (IQ/OQ/PQ Test Scripts), Deviations and Change Controls
• Knowledge of GAMP, GxP’s (GCP, GLP and GMP), 21-CFR Part 11 regulation of Electronic Records, Electronic Signatures and Audit Trails. Very motivated to learn and further my knowledge of the Manufacturing Industry as well as expand my knowledge of Quality Control Inspection.
• Experience in Software Development Life Cycle (SDLC), familiar with Waterfall, Liquid Chromatography, V-shape model and agile model.
• Well-versed with Quality Management System Trackwise which is used for Change request Management, CAPA and other investigations. 

PROFESSIONAL EXPERIENCE

Moderna, Norwood, MA

January 2023 – Present

Technical Writer

• Wrote technical reports for issues related to client’s facilities. Reports are submitted to the FDA for audit and review. Training included event management, CAPA processes, and deviation management. Assists the QA Manager in implementing and maintaining standard operating procedures (SOPs), validation and process development protocols, reports, deviations per (GMP) and FDA guidelines.
• Validated templates and results workflow for Veeva vault Quality Docs.
• Issuance of Batch Records, forms and related documents following compliance of SOP's and c GMP's. 
• Provided technical Deviation writing support to meet Release and Project documentation requirements.
• Provided subject matter expertise by supporting the overall direction, coordination, and implementation of Quality Assurance for the project.
• Risk management activities included performing FMEAs, implementing risk prioritization, risk mitigation, and risk control strategies for therapeutic protein development, clean room suites, cell culture bioreactors and large-scale chromatography systems.
• Worked to mitigate the process flow by monitoring deviations, CAPA’s, and change control.
• Performed activities related to drafting deviations, events and creating child action records utilizing Veeva vault.
• Performed investigation by interviewing analysts, examination and analyzing all executed production records, CC forms, ARNs etc.
• Prepared Standard Operation Procedures (SOP’s) by adhering to cGMP standards and other appropriate regulations. The project involved validation of TrackWise software, which is used for Audit Management, Product Quality Complaints, Deviation Handling, Training Management and Change Control in compliance with cGMP, FDA norms and 21CFRpart11.
• Validated Instrument / Equipment's such as chromatograph, bioreactors, autoclaves, and Incubator in compliance with FDA regulations. Wrote / executed revalidation life cycle protocols and final reports: cleaning validation, equipment qualification, media fills, steam in place.
• Created business use case, user requirement document (URS), functional (FRS) and technical documents for trading system.
• Mentored CAPA teams for process improvements, gap closures and deviation response.
• Drive and direct the technical oversight and timely execution of new product launches, cost reduction initiatives, technical investigations, product transfers, and process validation of innovative, high-quality solid oral drug delivery systems through the application of advanced science and technology, global teamwork, and sound business practices.

June 2019- June 2022

Technical Writer

• Responsible for writing deviations, action plans, effectiveness checks, trend reports. Assist with audit response development. Applies GMP in all areas of responsibility, as appropriate.
• Worked on Change management activities including – CAPA, Deviations, and Change actions.
• Participated in requirement gathering and analysis meetings to understand the requirements to create detailed manual test cases for implementing document management system Documentum, Sharepoint, and Veeva vault Quality Docs
• Responsible for Change Control activities for Automation and Process Engineering groups for Cell Culture Plants 1 and 2.
• Provided administrative support to the Quality and Testing teams by providing test reports and production, quality, and test documentation so that proper root cause analysis and quality investigations can occur if needed.
• Followed full document lifecycle and integration procedures. New project workflows included Deviation/CAPA/Change control initiation, risk assessment, impact analysis, Risk analysis, traceability matrix, Root cause analysis, test scripts and system project plan.
• Authored Impact Assessment, Trending Analysis using Access Database, Deviation Summary, Root cause, and Corrective and Preventive Actions (CAPA)
• Worked on Fish-Bone diagrams to determine the root cause of every major deviation.
• Reviewed piping and instrument diagrams (P&ID’s) for bioprocess equipment for compliance to cGMP principles.
• Authored drafts for Corrective and Preventive Actions (CAPA)
• Performed regular follow-ups with end users to ensure timely completion of open investigations and investigation activities. Ensuring CAPAs are instituted in a timely manner to prevent reoccurrence.
• Developed and supported the clinical and GMP activities for vaccine development and production by initiating, editing, and tracking reports, protocols, and quality systems documents. Author controlled documentation within the documentation system. Organize material and complete writing assignments according to set standards regarding order,

  Clarity, conciseness, style, and terminology. Document, investigate and obtain resolutions for deviations obtained in IOPQs execution.

• Analyzed controlled documents for inconsistencies, gaps or errors to drive process quality improvement and compliance with company standard operating procedures. Provide IT support QC Laboratory benchtops equipment and computers, printers, workstation monitors and implement technical refresh and application upgrade for Software.

May 2016 – May 2019

Technical Writer

• Supported and owned various quality system records such as deviations, change controls, CAPAs, and OOS/OOT investigations for cGMP Quality Control (QC).
• Review Master Batch Records, perform change control assessments and provide support to resolve deviations, CAPAs, and investigation process for GMP batches.
• Risk management activities included performing FMEAs, implementing risk prioritization, risk mitigation, and risk control strategies for therapeutic protein development, clean room suites, cell culture bioreactors and large-scale chromatography systems.
• Implemented and communicated any changes to quality process to the Technical Deviation Writers.
• Reviewed & released analysts' test results for cGMP & FDA compliance.
• Reviewing and approval of GMP manufacturing production batch records and master production records, QC qualification
• Authored and supported Chemistry, Bioassay, Microbiology lab investigations/deviations as well as investigations for Quality Control lab support functions.
• Worked with Quality Assurance to close deviations in a timely manner.
• Document deviations, quality event investigations and ensure they are reviewed and analyzed. Recommend studies, tests, new procedures, SOP’s, trainings, or validation activities to be performed.
• Supported development of Standard Operating procedures SOP’s and Work Instructions for process control by documenting and reviewing (SOP’s) for the various functions of the systems.
• Design the structure for the GMP Operations and Quality Control investigation process.
• Developed validation deliverables for all phases of Systems Development Life Cycle in accordance with FDA regulations. Ensure that all quality, production, and testing documentation is properly scanned and stored to track the life cycle of the units for any future quality issues that might arise. 
• Performed remediation and validation of legacy and new computer systems - GLP and GMP assessments, GAP assessments, writing validation plans, user requirements, functional specifications, IQ, OQ, PQ and summary reports.

Masters in health information technology