- Over all 7+ years of experience in IT Professional with in - depth knowledge and extensive experience in IT Computer System Validations, Compliance, Medical Device Manufacturing Validation, SPC, Laboratory Instruments/Manufacturing Quality System Validation, Computer Quality Assurance and System Development Lifecycle in FDA regulated environments.
- In depth knowledge of Medical Device Quality Management System (QMS), Development, System Integration, Sensors, Product Requirements Specification, Verification and Validation, Test Methodologies, Regulatory Compliance, Project Management and Vendor Management
- Extensive and diversified experience as Validation Engineer in packaging equipment and pharmaceutical industry with compliance to FDA 21 CFR Part 11.
- Understanding of development process and working knowledge of FDA, GCP, GLP and GMP requirements.
- Specialized in implementing risk-based IT Quality Systems in line with System Development Life Cycle (SDLC) requirements and, developing standards, policies and procedures in GxP (GCP/GLP/GMP) regulated environments.
- Experience in Quality/Regulated environment and implementation of Quality Systems for software adhering to ISO 14971, ISO 13485 standards.
- Experienced in the use of agile approaches, including Extreme Programming, Test-Driven Development and Scrum.
- Experience in Computer System Validation, Medical Device Manufacturing Validation, SPC, Laboratory Instruments/Manufacturing Quality System Validation.
- Expertise in developing and executing Validation Protocols (IQs/OQs/PQs) and construction of Validation Summary Report (VSR).
Confidential, Spencer, IN
Software Quality Test Engineer
- Core team member in transferring the production of Class III medical devices from a previous OEM. Provided support in quality disciplines, decisions, and practices, applying systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Constructed, developed and performed TMV for fabric tensile strength and elongation testing to support new supplier qualification activities.
- Performed test method validations and IQ/OQ's Wrote and executed Gauge R&R studies. Used FMEA analysis to determine root cause of problems
- Developing, evaluating, improving, and documenting manufacturing and manufacturing engineering processes
- Provided engineering support for several product-manufacturing lines with responsibilities such as, but not limited to equipment qualification, equipment troubleshooting, performance evaluation, engineering studies and process improvement projects.
- Transfer project: Worked in this manufacturing facility for transfer project for urology: mid urethral sling system for stress urinary incontinence and pelvic floor reconstruction such as Transobturator tape/sling system
- Worked in NPD/NPI as well as worked on process validation and quality documents, design of tools and fixtures .
- Responsible for ensuring completion of the CAPA/NCR activities and adherence to the CAPA process, as well as, responsible for ensuring the completion of CAPA deliverables and Stage Gate Reviews; assembling a team, define scope, establish timelines, and ensure execution of all elements of the CAPA process.
- Utilized knowledge of regulatory requirements of 21 CFR Part 210, 21 CFR Part 211, 21 CFR Part 820 to ensure regulatory compliance.
- Reviewed design history files (DHF), verification and validation (V&V) methods, SOPs, component drawings, and determined areas of need to meets QSR 820 compliance
- Experience using continuous improvement tools, such as FMEA, Root Cause Analysis, SPC analysis and process mapping.
- Used Six Sigma DMAIC methodology for corrective actions, Design for Six Sigma (DFSS).
- Responsible for processing document change requests though document /change control system (Agile & Windchill).
- Strong knowledge and application of process, equipment and test method validation techniques, PFMEA's, and associated regulatory requirements.
Confidential, Louisville, CO
Software Validation Specialist
- Worked on Capital equipment to support the design, development, test, and market release of software used in both surgical navigation applications and other medical devices.
- Contribute to the process and tools used to create and test software applications and develop and assess the quality programs and systems of Confidential Navigation to applicable standards.
- Provide guidance on Quality System Practices as defined by Confidential Navigation Littleton’s practices, policies and Standard Operating Procedures to ensure that FDA, ISO and European Medical Device quality standards and regulations are met where applicable.
- Actively participate in product development cycle to ensure Quality issues are addressed and resolved prior to release. Work closely with R&D to develop appropriate qualifications, validations, risk analysis assessments for system software, including reliability assessment for both new design and changes to released product. Assure the resolution of all software issues raised by the Test Engineering group.
- Assess, provide recommendations, and lead implementation of systems, processes and equipment for improvement and compliance to Good Manufacturing Practices within the R&D, Operations and QA/RA processes to ensure safe and effective products are produced. Provide written reports and supporting documentation for recommendations.
- Participate in problem solving efforts to isolate and resolve recurring and new software quality issues to ensure production of safe and effective medical devices.
- Participate in software complaint investigations, provide recommendations for dispositioning of anomalies. Ensure documentation and findings are completed in a timely manner and in compliance with FDA and European Regulatory agency standards and procedures; recommend and implement actions or changes to improve quality.
- Conduct risk management activities and recommend an appropriate course of action via CAPA systems.
- Devise, implement, and conduct methods and procedures to validate non-product software tools utilized in the production environment
- Use of HP ALM Quality center for defect tracking and reporting of bugs.
- Assisted other project team members in validation activities while interfacing lab equipment and analyzers through Computer System Validation.
Confidential, Pearl River, NY
- Provide validation services support for IT department and computer system validation in Pfizer Global Manufacturing facilities.
- Responsible for preparation of Validation Plan, SOP's, Installation, Operational and Performance qualification protocols including the execution of protocols and developing the corresponding reports for the laboratory equipment and computerized systems.
- Assigned to provide support in the qualification and implementation of LIMS, Empower and other laboratory system validations.
- Wrote, reviewed and approved computer SDLC documents such as User, System Requirements, Design Specifications, Validation Plans, Qualification Plans, IQ, OQ, PQ Protocols, Test Scripts, Risk Assessments and Traceability Matrices as per corporate SOPs and Good Manufacturing Practices for local IT hardware (servers/network), enterprise systems (e.g. GxPharma) and custom applications.
- Ensure corporate and site computer systems are assessed for regulatory compliance, implemented, and validated according to company policy and industry regulations
- Responsible for ensuring compliance to site procedures, corporate conformance standards, and industry regulations for GxP Computer Systems site-wide. This includes Enterprise systems, Laboratory computer systems, and Capital Automation projects.
- Developed Standard Operating Procedures (SOPs) based on the business requirements gathered for Validation Plan, Test Cases and Test Procedure.
- Duties included computer system validation and documentation of all materials during the testing phase of the project.
- Executed the tests developed, coordinating simultaneously with the QA department
- Helped qualify the terminals and machines for optimal configuration using Installation Qualification (IQ) and Operational Qualification (OQ)
- Liaison between the IT Department and the site Quality Assurance Department to ensure approval of IT produced CSV, SDLC deliverables and other Quality Records.
- Managed system upgrades, enhancements, and maintenance in a cGMP environment
Confidential, San Francisco, CA
- Responsible for the carrying out retrospective and prospective qualification/validation activities for Confidential ’s IT Infrastructure and electronic Software Application Access Request Form (eSAARF)
- Reviewed and approved validation documentation ensuring GMP impacting IT systems are in compliance with all regulatory requirements and internal policies & procedures.
- Involved in Computer System Validation Engineers assigned to all projects and supported other validation functions as required or requested (generating validation documents, executing test scripts).
- Assisted IT Department in developing IT validation procedures and system owners with system use procedures.
- Developed project plans, detailed communications plan, project deliverables, risks assumptions, Infrastructure Qualification Guideline as part of the Network Infrastructure Qualification Project for worldwide site Developed, reviewed validation deliverables from different sites in accordance with FDA 21 CFR - Part 11 & 211, EU Annex 11 while maintaining a standard approach towards validation process and executed qualification protocols and test cases.
- Developed and provided user training on Part 11 compliance, Computerized System Validation (CSV), IT Infrastructure Qualification, Good Documentation Practice (GDP), test execution and deviation/incident handling.