Provide auditing and other quality and compliance consulting services to pharmaceutical companies and pharmaceutical supporting industries. Services have included on-site quality and compliance audits of client's facilities, GMP audits of contract manufacturers and suppliers, designing audit programs based on risk assessments, pharmaceutical auditor training, and general quality assurance system reviews and support.

Implemented, managed, and maintained the supplier audit program. Responsible for the oversight of approximately 5,000 GMP suppliers ensuring audits are completed within the published timeframes, audit findings are documented and reported to senior management, and appropriate audit follow-up occurs.Additionally, between March 2008 and March 2010, directed the commercial GMP audit planning and scheduling function for approximately 1000 audits performed annually. Assure risk based approach is employed across all GMP Programs to target high risk areas, assure audits are efficiently scheduled and qualified auditors are assigned to perform specific audits

Supplier/Contractor Audits, Global Compliance Auditing Directed a team of audit managers / senior managers to assure that GMP audits are performed timely, professionally, and consistently against industry guidances, BOH expectations, and Wyeth policies. Reviewed GMP audit reports for completeness and clarity. Wrote and approved SOPs for the operation, scope, and interactions of the department.

Supplier Audits, Global Compliance AuditingOrganized, coordinated, and conducted worldwide GMP audits of Wyeth facilities, contract manufacturers, and suppliers. Assessed capabilities, operational controls and regulatory compliance and communicated findings and risks to management. Recommended and monitored corrective actions to minimize compliance and business risks.

Organized, coordinated, and conducted worldwide GMP Regulatory Compliance audits of facilities, commercial and R&D sites, related contractors, and potential business acquisitions worldwide. Coordinated and managed multiple concurrent regulatory compliance projects.

Managed the compilation and review of documents for new filings, (NDA and MAA), and Annual Reports. Facilitated GMP audits performed by contractors and regulatory agencies and prepare/compile responses to audit observations. Performed internal and external GMP audits including contract manufacturing sites, contract laboratories, and packaging component vendors. Reviewed batch documentation, product investigation reports, site SOPs, and Validation Reports.

Managed the Qualification, Validation, and Validation Maintenance for all manufacturing processes, equipment, and systems in the Anti-Infective and Containment facilities. Facilitated the development of validation protocols, coordinated testing, analyzed data, reviewed reports, and ensured that all validations were performed in compliance with GMPs and appropriate BOH regulations and guidelines.

Managed the Product Assurance department for the Anti-Infective, Containment, and Bulk manufacturing facilities. Coordinated sampling and testing of packaging components and raw materials. Performed in-house auditing of each department. Administered the site vendor auditing program for raw materials, packaging components, and labeling. Responsible for new labeling and the maintenance of all current and historical labeling. Performed batch record and documentation reviews of Product Assurance Inspection reports.

Managed the Chemistry and Particulate Matter Sections of the Anti- Infective and Containment Quality Assurance Laboratories. Coordinated QC release tests, Stability tests, Method Development/Validations, Analytical Instrumentation Qualifications and other special projects to ensure that all tests are performed according to GMPs and were completed according to schedule. Provided timely annual updates to NDAs. Interpreted and implemented BOH guidelines relating to GMPs and Laboratory Out of Specification investigations. Evaluated compendia and published chemical methods and new equipment for possible inclusion in laboratory operations. Provided input and support to manufacturing and cleaning validations. Audited suppliers, contract manufacturers, and contract laboratories to ensure GMP compliance and specified company standards. Represented company on the PhRMA Particulate Matter Committee.

Supervised the Chemical Reference Standard Program. Coordinated and reviewed reference standard characterizations, storage, and distribution. Provided support for ongoing Chemical Development Projects in house and to other sites within the Chemical Division. Provided technical support for the transfer of analytical methods from R&D to Chemical and Pharmaceutical manufacturing sites worldwide. Liaison with other departments, (Regulatory Affairs, R&D, Consumer Brands, Pharmaceutical Manufacturing, etc.) regarding analytical, regulatory, and quality issues. Prepared and reviewed regulatory documents (DMFs, NDAs

Provided analytical method transfer, training, and support to Chemical and Pharmaceutical manufacturing sites worldwide. Supervised and coordinated analytical support for Chemical Development projects.

Provided analytical support to Chemical Development Projects. Isolated and characterized impurities and degradation projects. Developed and validated new analytical methods, (GC and HPLC), for drug substances.

Tested raw materials, intermediates, and drug substances according to GMPs using various analytical techniques and instrumentation, (HPLC, GC, IR, UV, TLC, TGA).GARY E. TOMLIN

Developed and validated HPLC stability indicating methods for veterinary drug products. Scheduled analytical testing to conform to stability protocols. Maintained stability files. Statistically evaluated stability trends and recommended expiration dates for products.

Assayed raw materials, intermediates, and finished products using wet chemistry and analytical instrumentation. Monitored chemical processes and documented any abnormalities. Wrote formal laboratory reports to plant sites within the division.