Annapolis, Maryland, United States
SUMMARY OF QUALIFICATIONS • Experienced professional with over 25 years in the biomedical industry • Expert in Quality Assurance and Validations • Specialist in Project Management for Facilities Development, Equipment Installation, Commissioning and Consent Decree activities. • Skilled in Research & Development
• Assist in scoping and development of validation plans in conjunction with the CQV vendor that is the primary author. • Lead and support a team of CQV engineers in the development and execution of validation documents. • Ensure that all validation activities comply with regulatory requirements, GSK standards, and industry best practices. • Conduct thorough reviews of all validation documentation to ensure accuracy, completeness, and compliance. • Generate wrapper documentation for FAT/SAT documents for all equipment packages. • Provide feedback and guidance to CQV engineers on document preparation and improvement. • Support change control development and final approval. Related functions (Ex. EM Risk Assessment), providing final review and approval.
• Wrote validation plan to perform IOQ, reclassify, recovery test, air flow visualization testing and EMPQ testing for cleanrooms. • Wrote documentation for IOQ, reclassify, recovery test, perform air flow visualization testing and EMPQ cleanrooms. • Created scheduling plans and conducted scheduling meetings with project management team, facilities, engineering, internal validation, QC and QA. • Review specifications and vendor documentation. • Supervise execution of the IOQ, reclassify, recovery test, perform air flow visualization testing and EMPQ cleanrooms and coordinate the completion of final reports.
• Perform start up activities for water generation systems, clean steam generation systems, distribution systems, storage tanks, and process gas/air systems. • Write documentation for CQV and PQ of water generation systems, clean steam generation systems, distribution systems, storage tanks, and process gas/air systems. • Perform commissioning and qualifications of the follow systems monitored by DeltaV and VDS: water generation systems, clean steam generation systems, distribution systems, storage tanks, and process gas/air systems. • Review specifications and vendor documentation, perform field verifications.
• Review and approve protocols for process, equipment, facilities, computer, and utility validation and associated reports. • Review and approve protocols for QC analytical, micro, and bioanalytical studies and methods validation and data. • Review master batch records, executed batch records, process formulation, filling, packaging, and labelling. • Write and review deviations, CAPAs and change controls and/or perform investigations and root cause analysis. • Provide support for internal audits and regulatory inspections.
• Review and approve validation master protocols, executed validation protocols, deviations for validation protocols and validation final reports. • Review and approval of Engineering drawings and ETOPs.