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Professional Experience
• Responsibilities include supervising QA/QC activities and associated staff. Responsible for
improving quality systems in accordance with CGMPs and QSR to prepare for Phase 3
manufacturing.
• Evaluate departmental resource needs and develop budget recommendations; oversee training
and development of staff; review and approve all departmental reports.
• Responsible for improving quality systems in accordance with all government regulations
and consistent with CGMPs to prepare for Phase 3/launch manufacturing. Includes CAPA,
investigations, deviation reporting, change control, vendor qualification, and audit program.
Member of the selection team for a Quality Management System. Reviewed and approved
validation master plan and qualification documents for the validation of TrackWise®.
• Directed validation efforts for a newly constructed Class 10,000 manufacturing facility
(facility/HVAC/BCS, autoclave, WFI, RODI, isolator/filler, VHP, depyrogenation oven, vial
washer, process and QC equipment). Key participant in the selection of process and
manufacturing equipment and in the overall design of the manufacturing facility.
• Assisted in the development and supervised the Part 11 compliance plan. Reviewed and
approved the validation master plan, qualification documents, and required SOPs for network
qualification and QC equipment.
• Assisted in the preparation of CMC sections of regulatory submissions. Received 2004
outstanding achievement award as member of the CMC team.
• Active member of the Supply Chain Management team
• Active member of the Packaging and Labeling team to develop materials for launch and
commercial manufacturing
• Initiated preparation for Pre-License Inspection
• Implemented personnel and job-specific training program
• Directed all internal and external audits (GMP, GLP, GCP, vendor qualification for raw
materials, test facilities, and CROs)
• Developed and directed execution of cleaning validation project. Drafted cleaning validation
master plan.
• Extensive involvement in technology transfer of new manufacturing process. Assisted in the
development of production batch records and provided input on testing requirements.
• Approved and released product for clinical trials
• Strategic, operational, and human capability planning for the QA department and personnel.
Evaluated departmental resource needs and developed budgets.
• Responsible for developing and implementing quality systems in accordance with all
government regulations and consistent with CGMPs to prepare for Phase 3 manufacturing
T. Moore
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• Directed validation efforts for a newly renovated facility (autoclaves, WFI, purified water,
batchwasher, facility/HVAC, cleaning, misc. manufacturing and QC equipment). Hired and
supervised validation consultants as their primary liaison. Developed Validation Master Plan.
• Oversaw all contract testing (review and approval of study protocols and final reports,
scheduling, etc.). Evaluated and selected new contract test facility to perform 70% of all
product testing.
• Participated in the preparation of manufacturing, control, and other technical sections of
regulatory submissions (Pre-IND documents and two INDs)
• Project Management training: Project Leader for GxP compliance plan dealing with facility
and equipment, personnel, materials, methods, and quality systems
• Retained all responsibilities from previous Associate Director, QA/QC position: approve
product for clinical trials; evaluate departmental resource needs and develop budget
recommendations; oversee training and development of staff; review and approve all
departmental reports; direct all internal and external audits.
• Directed all Quality Assurance systems, including the establishment of a formal auditing
program. Directed all internal and external audits.
• Oversaw all contract testing (review and approval of study protocols and final reports,
scheduling, etc.)
• Prepared and coordinated the compilation of manufacturing, control, and other technical
sections for FDA submission (20 Type II Master Files and associated amendments)
• Approved product for use in clinical trials
• Reviewed and approved all departmental reports, including deviations, problem
investigations, validation reports, and change control reports.
• Directed all training and development of the staff. Determined goals for the staff that were
consistent with company objectives and goals.
• Evaluated resource needs for the department and prepared budget recommendations for staff
and equipment
• Directed the technical transfer of assays from Assay and Process Development to Quality
Control
• Coordinated technology transfer from Process Development to Manufacturing to ensure that
changes were consistent with QC sampling and testing methods
• Directed all aspects of Quality Assurance, such as validations (autoclaves and other
equipment, aseptic media fills), CGMP training, and auditing of contract test facilities
• Responsible for managing all QC activities, such as the operation of the QC laboratory,
including planning, test development, supervision of QC analysts, and approval of QC test
results
T. Moore
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Education
M.S. Medical Microbiology, Northeastern University
B.A. Biology, Susquehanna University
Professional Affiliations
Parenteral Drug Association
Institute of Environmental Sciences and Technology
International Society for Pharmaceutical Engineering