Validation ProfessionalIndustry-Related Experience Since: 1998Summary of Qualifications• Over twenty years of experience supporting biotech, pharmaceutical, and medical device manufacturers.• Aided in the development of multiple Corporate Standards and Operating Procedures for multiple companies.• Divisional representative and subject matter expert on Utilities Qualification on various Corporate Teams.• Technical Experience includes:• Performing system evaluation related to 21 CFR Part 11 compliance• Development and execution of Test Method, Equipment IQ/OQ/PQ, Cleaning, and Process Validation documents consistent with cGMPs and cGLPs. • Risk management using FMEAs, FTAs, and gap assessments • Authoring of standard operating procedures/corporate policies• Utility projects have included HVAC, WFI, PW (USP), and Compressed Gas qualifications along with the validation of their associated controls.• Facilities projects have included qualifications of new facility construction, building reconfigurations, facilities for animal research and manufacturing areas, and validation master planning.• Validation of diagnostic assay manufacturing processes and qualification of their associated test instruments.• Authoring of Validation Master Plans for Site Utilities and Manufacturing Processes.• Work experience within QC/QA departments• Conducted and aided investigations related to for OOS results and related discrepancies.• Developed, executed, and resolved CAPA system action items to reconcile any observations from regulatory and internal audits.• This experience includes working with/qualifying various building control and monitoring systems.• Recent activities includes management of site cleaning validation activities, temperature mapping studies (autoclaves, cold/warm rooms, large capacity freezers, and warehouse storage areas), and various types of equipment qualification activities.
Listed skills include Validation, Capa, 21 Cfr Part 11, Change Control, and 44 others.