Vanessa Levy Email and Phone Number

Pharmaceutical clients have included Sanofi Pasteur, Merck, McNeil Consumer Healthcare, Janssen Pharmaceuticals, Teva Pharmaceuticals, and MTA Authored, reviewed, executed, and provided guidance for quality assurance plans, requirement/configuration/design specifications, test documents (including unit test/code review/system test/UAT, test plans, test summary reports), quality assurance summary reports, SOPs, and other related documents for custom and configured off-the-shelf software packages Oracle Argus Safety Adverse Event Reporting System and Werum PAS-X Manufacturing Execution System (MES). Managed investigation, resolution, documentation, and closure of test events and system defects for a Werum PAS-X Manufacturing Execution System. Partnered with multiple Quality personnel, including consent decree independent GMP verifiers, to ensure the quality of the MES validation documentation.Authored validation, commissioning, and qualification protocols and reports, policies, procedures, specifications, and work instructions, working within cross-functional teams including Quality, Engineering, Analytical, and Operations personnel.Process Performance Qualification for formulation and filling of sterile vaccine products, including a COVID-19 vaccine, shipping qualification.Coordinated filter validation studies for sterilizing in-process, critical, and vent filters. Composed final reports for the filter validation studies, summarizing results and providing recommendations for future testing. Calculated per-dose amounts of leachables observed in the filter validation studies to determine acceptability of filter use. Conducted filtration development studies to determine adsorption profiles for critical quality attributes of a vaccine formulated bulk product and provided recommendations for pre-use flush procedures for the filter.Evaluated leachables analytical data for product-contact single-use assemblies.

Supported global cross-functional IT project teams by providing quality assurance oversight to the teams on testing strategies, problem and incident resolution, risk assessments, SOP updates, application and data changes, and overall compliance to corporate and regulatory requirements.Performed audits of internal groups and external vendors to determine the acceptability of their software engineering processes and to determine the areas’ adherence to cGMPs.Provided training to internal groups on System Life Cycle processes, change control, GAMP, good documentation practices, and USP <1058>.Analyzed quality incidents to provide the ability to create a metric to drive process improvements.Reviewed, provided guidance for, and approved quality assurance plans, requirements specifications, test documents (including IQ/OQ/PQ, test plans, test specifications and cases, test summary reports), quality assurance summary reports, SOPs, and other related documents.

Developed system life cycle documents for laboratory instruments.Executed system life cycle documents for various laboratory instruments.

Developed OQ protocols for CIP/SIP skids, diafiltration equipment, chromatography columns, refrigerators, cold rooms, cryogenic freezers, incubators, biosafety cabinets, and process gases. Developed system life cycle documents for laboratory instruments.Executed IQ/OQ/PQ documents for various laboratory instruments including HPLCs, Surface Area Analyzer, Differential Scanning Calorimeter, X-Ray Diffractometer, TECANs with Gemini Software, Mass Spectrometer, Sequence Detection Systems, Cell Viability Analyzer, Spectrophotometers, Spectrofluorometers. Led a group of three validation specialists to complete the execution phase of computerized instrument validation projects.

Developed and validated HPLC test methods for cleaning verification, assay, related substances, content uniformity, and dissolution of pharmaceutical capsule and tablet dosage forms.Prepared method validation protocols and final reports. Performed testing on cleaning verification samples according to company methods.Performed testing on product development samples according to USP and company methods.Composed SOPs for peak purity and forced degradation studies using Empower software and a photostability chamber. Systems: Waters Alliance HPLC systems, Empower software, Distek Dissolution Apparatus.

Developed and validated HPLC methods according to FDA and ICH Guidelines.Prepared method validation protocols and reports.Conducted stability and release testing on developmental drug products in a cGMP laboratory, working primarily with cream formulations.Evaluated problems with a calibration procedure and investigated solutions by contacting the vendors and performing lab experiments.Systems: Agilent and Waters Alliance HPLC systems, Millenium32 software

Performed release testing on drug products, excipients, raw materials, and packaging components in a cGMP quality control laboratory.Systems/Methods: Agilent HPLC, Nicolet IR Spectrometers, USP/EP monographs.

Validated HPLC and GC methods.Performed stability testing for many clients in a cGMP laboratory.Provided training on equipment and data analysis software.Systems: Varian and Hewlett-Packard (Agilent) HPLC systems and Brinkmann Metrohm Volumetric and Coulometric Karl Fischer Titrators.