Healthcare - Health Services
Creative & Design
Education and Experience:
At least two years experience in experience in the validation of computer systems, manufacturing, packaging, equipment and process, as well as utilities, and facilities qualification.
Must have thorough understanding of FDA regulations and computer validation guidance documents
Bachelor's degree in computer science, technology or related field required
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Experience in thorough testing of applications, computerized systems, changes and implementations.
Familiarity with the following systems: MES, QAD, ERP, Document Management, HP Quality Center and Quality Records Management.
Familiarity with GAMP and other approaches to System Development Life Cycles (SDLC), CAPA.
Computer knowledge of 21 CFR Part 11, CFR 820Excellent communication skills and customer service orientation
FDA Compliance experience preferred.
Machine, Tools, and/or Equipment Skills:
PC servers, workstations and laptops. Microsoft environment. Work with standard current computer applications, such as word processing, spreadsheets and data bases.