- Motivated and results oriented engineer by increasing responsibility in diverse functions within the Engineering Applications and Medical Device industry by developing, executing and managing improvements to product design, manufacturing processes / Operations and Quality Systems.
- Experience in creating validation documentation deliverables, which include Validation Master Plan and Strategies, Requirements Specification Documents, Technical System Design, IQ/OQ and Migratsion Protocols, Validation and Verification protocols, Validation Reports and Traceability Matrices by assessing 21CFR Part 11 compliance applicability
- Strong ability and understanding on development, reviewal, execution and approval of qualification protocols (IQ, PQ, OQ) and other validation lifecycle documents.
- Strong Understanding on various ICH, FDA guidelines used in pharmaceutical development, cGXP's (GMP, GLP, and GCP) and GAMP 5 model used for typical computer system validation projects.
- Excellence leader driving QMS elements to implementation according to regulations requirements from FDA - QSR 21 CFR 820, 21 CFR Part, ISO 9001, IEC 60601, 14971, 13485, CMDR, MDD, and ISO 14971, IEC 62304.
- Waters Empower CDS subject matter expert, served as lab admin liaison to IT resources
- Strong administrator level experience with Validation Life Cycle Management leveraging both paper based process as well as the Electronic based process using ValGenesis Life Cycle Management system.
- Configured, Commissioned and Validated, TrackWise, SAP report, Mercury report, Crystal report, and labware LIMS.
- Experience in conducting automated testing, traceability matrix and defect management.
- Good understanding of Lean six sigma methodology, Root cause analysis, Corrective and preventive action (CAPA) and Failure Mode Effect Analysis (FMEA).
- Experience in performing FMEA analysis, Gap Analysis and Risk Assessment.
- Knowledge of Corrective and Preventive Action (CAPA) Gage R&R. Root Cause Analysis and Design of Experiment (DOE).
- Knowledge and experience of using analytical lab instruments such as Centrifuges, Autoclaves, Incubators, UV Spectrophotometers and HPLC
- Experience in authoring and reviewing requirements and test scripts and test cases as per SDLC methodology
- Experience in design, development and testing of medical devices.
- Able to work efficiently in both individual and team based environment
- Excellent problem solving, analytical ability as well as oral and written communication skills
- Experience working with stakeholders and facilitate communication between client and IT department.
Computer System Validation: 21 CFR Part (11, 50, 56,210,211,820), cGxP (cGMP, cGDP, cGLP), GAMP5, IQ, OQ, PQ, RTM, Summary Reports, Audit Trails, Gap Analysis and Remediation Plans, FMEA,LIMS
Testing and Tracking Tools: HP Quality Center(HPQC), Win Runner, Trackwise EQMS, Documentum (PDOCs), Solution Manager, JIRA,QTP, SAS
Methodologies: Waterfall, RUP, Agile, SDLC and GRC
Scientific Software: Working Exposure to Lab view, MATLAB, Eagle and Tina Pro
Languages: C, C++,HTML, SQL
Other Tools: MS Office, MS Visio, SharePoint
Confidential, Memphis, TN
- Effective CAPA investigator for root causes analysis and impact assessment of nonconformance, including CAPA plan design, and effectiveness verification of CAPA implementation for quality issues.
- Create/update validation documentation deliverables, which include Validation Plan and strategies, Requirements Specification Documents, Technical System Design, IQ/OQ and Migration Protocols, Validation and Verification protocols, Validation Reports and Traceability Matrices by assessing 21CFR Part 11 compliance applicability.
- Work with CAPA and task Owners to manage the CAPA lifecycle from identification / investigation through effectiveness. Provide Subject Matter Expert (SME) guidance and CAPA management system technical support when required.
- Involved in auditing the application for 21 CFR part 820, IEC 60601-1, ISO 13485, and ISO 14971. Compliance related to Electronic Signatures and Electronic Records for Trackwise System.
- Review and approval of all investigations resulting from validation activities and creating and monitoring the execution of CAPAs through Track Wise System.
- Executed CAPA reports for reducing lab investigations and continuous laboratory improvement.
- Performed risk management activities using Failure Mode Effect Analysis (FMEA) techniques to identify potential failure modes on pharmaceutical and medical device manufacturing equipment.
- Implemented cGXP's (GMP, GLP, and GCP) and GAMP 5 guidelines in the systems.
- Support the development and implementation of Quality System CAPA: procedures, software, and programs.
- Assessed failure of previous implementation of Product Development Process program for this manufacturer of Medical Devices and Instruments.
- Support computer system validation efforts for system used in GMP, 21 CFR Part 11, and 21 CFR Part 820. Management of CSV project schedule and resources including contract employees.
- Executed and authored IQ, OQ, PQ and PV protocols within the GMP area for various packaging and process equipment as well as temperature mapping studies.
- Assured that all system’s validation documentation such as IQ's, OQ’s, and PQ's are in compliance with cGMP's (21 CFR Part 210/211).
- Design Quality Engineer specializing in design controls, risk management, and process improvement.
- Identified compliance gaps with Quality Systems (i.e. Quality Agreements with third party sites, incorrect specifications, overdue CAPAs, etc.) and recommended deviations and CAPAs to address these gaps.
- Writing SOPs on Operating, Maintenance and Cleaning Procedure for Equipment/ Instruments and Manufacturing and Packaging processes.
- Involved in writing and execution of test scripts and requirements specification verification documents (RSVs) based on SDLC and GRC methodologies respectively
- Created, reviewed, edited, and approved Change Orders to support R&D, Manufacturing, Regulatory Affairs, and Quality improvements.
- Participate in the collection, analysis, and presentation of data in support of the Corrective and Preventive Action (CAPA) and Management Review process.
- Performed medical device product verification/validation (V&V).
- Created and reviewed Process flow diagrams, Business Integrated Model (BIM), Business Process Master List (BPML), Verification Strategy document (VSD), requirement documents and RTM for the projects
- Utilized Documentum and created documentation in all phases of the SDLC.
- Designed and authored Standard Operating Procedures (SOP’s) based on the business requirements gathered for Validation Master Plan (VMP) and Validation Protocols like Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)
- Quality Management Support Activities (QMS), Control Plans, Qualifications, Process Validations, gage R&R's along with Design Verifications and Design Reviews, and implementation of new manufacturing processes for new products
- Performed Positive & Negative Testing, End-to-End testing and manual testing
- Trained in Lean Sigma Green Belt, Design for Manufacturing and Testing.
- Conducted UAT (User Acceptance Testing) to make sure that all the user requirements are catered by the application
Confidential, Cambridge, MA
- Provided support to staff on the application of, and adherence to processes and systems used to manage Quality Issues (QIs)/Corrective Action Preventive Actions (CAPAs).
- Responsible for assisting in the implementation of software systems in compliance with regulatory requirements as they pertain to 21 CFR Part 11 and GAMP standards.
- Assist with the compilation, quality / regulatory accuracy, and completeness, of the QMS documentation required by Regulatory Authorities.
- Created and prepared QI/CAPA metric reports. Assisted staff in pulling departmental or project QI/CAPA reports.
- Performed Computer System Validation based on the companies’ validation SOP, SDLC and Regulatory requirements for equipment Capmatic On-Line Headspace Inspection and Labeling System.
- Assisted, developed, and delivered s on QI/CAPA management. Provide monthly forum presentations to the company regarding QI/CAPA management: best practices, new processes, .
- Analyzed user requirements and application regulatory requirements including 21 CFR Part 11 for Monostar consists of the label printer.
- Profound knowledge in pharmaceutical/medical device regulations like FDA 21 CFR Part 11, FDA 21 CFR part 820 and ISO 13485and GAMP regulations.
- Assist in development, review and approval of equipment validation/qualifications (IQ, OQ, PQ).
- Assist with quality processes to maintain Quality s (i.e. IEC 60601/ ISO 13485)
- Participate in the development of study-specific (CRFs) and source documentation forms, as needed for each study.
- Validation Subject Matter Expert for CSV activates performed by functional areas(e.g. analytical laboratory, manufacturing).
- Involved in generation and execution of process validation protocols for oral solid dosage forms.
- Developed site validation plan by supporting serialization project implementation on packaging lines.
- Worked in a strictly regulated cGXP environment for all the aspects of Computer Systems and Equipment Validation.
- Identified the applicable CSV deliverables to the project and drafted the Validation required elements.
- Maintained Regulatory compliance with ISO 13845, ISO 14971 Risk Management, FDA QSR and CMDR.
- Verified the closure of Event and CAPA Records.
- Developed and maintained IQ, OQ, PQ protocols for equipments like HPLC, GC, MS, Autoclaves, Freezers, Refrigerators, and other analytical laboratory equipment.
- Coordinated with the quality assurance team in updating and maintaining the SOPs for laboratory equipment.
- Performed troubleshooting, data analysis and acted as a regulatory liaison.
- Maintained the Requirement Traceability Matrix (RTM).
- Conducted User Acceptability testing and documented the User Acceptance Test Summary Reports (TSR).
- Contributed towards development of Validation Summary Report (VSR).
Confidential, Philadelphia, PA
- Verified if all validation protocols including IQ, OQ, PQ are in compliance with cGMP (21 CFR Part 210/211)
- Responsible for quality performance monitoring and evaluate internal process to ensure continued delivery of quality products and services.
- Involved in performing Packaging Validation to identify the defects.
- Execution and report generation of IQ/OQ/PQ/PV protocols for Liquids and Solid Dosage manufacturing, filling and packaging equipment.
- Developed Functional Requirements and Test Scripts for large scale SAP ERP implementation, maintaining traceability across design, user and functional requirements, and test protocols.
- Maintained CAPA procedure, initiated investigation of non-conformances through root cause analysis, evaluation of the effectiveness of CAPA process, and initiation of action as required improving effectiveness.
- Monthly status reporting to the management for progress, issues and risks.
- Participated in the assessments for the requirements of 21 CFR part11 and FDA regulations.
- Worked with medical and clinical data on annotated CRF, SDTM and ADAM data set level and created tables listing and figures in a format that can be reported to FDA (Medical Data Acquisition and Storage.
- On qualification/validation activities to 21 CFR, Parts 11 and 820, along with QMS ISO-13485.
- Collaborated with cross functional teams to facilitate Risk Management activities such as Design FMEA, Process FMEA and Risk Analysis.
- Developed IQ/OQ/PQ protocols understanding the Software Installation working with Vendor teams
- Developed migration protocols used to migrate system configurations and data as needed
- Liaison between R&D, Production/ Operation, and Quality throughout the process from R&D to validation tests (IQ, PQ, OQ) to meet IEC 60601-1 requirements to compile reports, data for FDA submission for next generation device to meet market launching date target.
- Review/Write and execute IQ/OQ/PQ Protocols for computer systems software validation to ensure that the system conforms to user specifications and business intended use and functions as expected
- Prepared validation plan (VP) for validating analytical laboratory equipment and also Labware LIMS integration with ELN.
- Developed support programs required to assure compliance with current Good Manufacturing Practices
- Review of GMP batch records, raw data, and laboratory documentation