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Patricia A. Williams10336 Treeline Ct. Telephone: 317-373-8142Fishers, IN 46037 Email: [email protected]
SummaryFocused and broad-based Quality Assurance expertise gained over 30 years of increased responsibility for auditing, quality system development, contract manufacturer oversight, and implementation of SAP and TrackWise. Responsible for implementation of quality systems following acquisitions of seven animal health businesses, making Elanco number three in the animal health industry.
Accomplishments and Expertise Auditing and self-inspections of APIs, parenterals, solid orals, premixes, EPA-regulated products,
and non-medicinal products Design and implementation of global and local quality systems Oversight of 20 global contract manufacturers and suppliers Application of GMP concepts to non-medicinal products; development of new quality system fit
for new product types Integration of new products and manufacturing sites resulting from multiple business acquisitions Launch of over 20 new products in new and existing business areas Implementation and use of SAP Quality Management; functional testing of multiple upgrades;
onboarding of new sites and users Implementation and use of TrackWise for deviations, changes, & audits; course development and
instruction of “train the trainer” sessions for global users Development of training curricula for quality assurance, technical services, supply chain, and
management departments; development & instruction of courses to support worldwide contract manufacturer oversight
Creation and support of document management systems including templates for procedures, quality agreements, specifications, validation protocols, stability protocols, deviations, and change controls
Supervision of QA departments authoring global quality standards and providing oversight for contract manufacturers; mentoring of new QA personnel
Work Experience – Eli Lilly & Company, Indianapolis, IN (1986-2017)Elanco Quality Assurance Consultant (2010-2017)
Oversaw contract manufacturers (site visits, validations, batch release, deviation approval, etc.), integrated new products and acquired sites, maintained the site quality system, addressed SAP issues, trained new TrackWise users, and mentored new QA reps
Elanco Quality Assurance Manager (2005-2010)Established the QA department for a new business unit and developed the site quality system
Global Quality Assurance Manager (2002–2005)Established a new department to design and implement a new global quality system including multiple layers of standards, document content & format, and coordination with technical experts
Global Quality Assurance Representative (1992-2002)Audited multiple internal sites and potential contract manufacturers; hosted regulatory agency inspections; consulted with internal sites on quality topics such as stability, cleaning, & biotech operations
Productivity Associate (1989-1992)Microbiologist (1986-1989)
EducationMaster of Science, Biochemistry – Case Western Reserve University, Cleveland, OH, 1986Bachelor of Science, Biology and Chemistry – John Carroll University, Shaker Heights, OH, 1983
