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Job Information
Job title

Computer Validation Auditor, Level II

Company PPD (Pharmaceutical Product Development, Inc.)
Wage between $0.00 - $0.00 Annually
Location United States, North Carolina, Wilmington
Employment type Full Time
Education Not Specified
Year Experience 4 - 5 Years of Practical Experience
Travel None
Published on 2/5/2007
Description
Position will be responsible for ensuring computer validation activities and company's use of electronic records are in compliance with internal procedures, policies, and applicable international guidelines and regulations. Conduct internal audits and review validation activities, documentation, and change control. Train employees on FDA requirements for electronic records and signatures (21 CFR Part 11).

Education and Experience:
?Bachelor's Degree or an equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills and abilities, 4 - 5 years experience in a high technology computer area performing testing, troubleshooting and validating including a minimum of 2 - 3 years experience in medical device or pharmaceutical industry with a general familiarity of U.S. FDA regulations pertaining to cGMP, cGLP, or cGCP. OR an equivalent combination of education and experience that provides the required knowledge, skills and abilities to perform the job.

Knowledge, Skills and Abilities:
?Experience with Oracle or other clinical database management systems.
?Experience with MS Word, Excel, PowerPoint, and Access.
?Must possess advanced knowledge of software development life cycle (SDLC).
?Demonstrated expertise on content of 21 CFR Part 11 and the application of this regulation in GLP and GCP environment.
?Experience with writing system requirements documents, validation plans, test cases, and validation summary reports.
?Ability to field sponsor's questions related to 21CFR11 issues.

PPD is an Equal Opportunity Employerdf-tc

Experience/Skills
See Job Description

Other desired skills:
Computer Validation Auditor, Level II
This job has expired.