Susan Gillham
Manager, Gxp IT Audit (IT Quality Assurance) @Bristol Myers Squibb
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WORK HISTORY
Manager, Gxp IT Audit (IT Quality Assurance) @Bristol Myers Squibb
Quality Assurance Unit auditor within Information Technologies Quality Assurance responsible for auditing all processes related to computerized system development, production use, maintenance and retirement to assess compliance with relevant e-record and e-signature regulations. The responsibilities of the position include but may not be limited to: planning, organizing, executing, and documenting audits of regulated computerized systems and related IT controls; review and assess corrective and preventive action plans; provide advice, training, and counsel concerning computer system regulatory requirements to staff and business stakeholders on computerized system/validation projects to ensure conformance to cGxPs, guidance documents, applicable industry standards and BMS requirements to assure compliance and inspection readiness.
EDUCATION
Murray State University
Animal Health Technology (area), Animal Health and Veterinary Sciences/Agriculture
SKILLS
ABOUT SUSAN GILLHAM
Self driven individual with strong leadership skills, technical experience in the pharmaceutical industry to include general animal handling and a vast knowledge Computerized Systems compliance, Histology and Immunohistochemistry procedures and practices. Knowledgeable in Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and Good Manufacturing Practices (GMP) compliance. Experienced auditor (internal, external vendor and on-site FDA inspections). Strong work ethic needing little to no supervision to successfully accomplish projects and achieve professional goals.
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