Validation Professional - 5064
Location: Franklin Lakes, NJ
Start Date: 02/21/2011
End Date: 08/19/2011
Job Description:
Computer Systems Validation Professional A minimum of 10 years of experience as a Validation Subject Matter Expert working in an FDA and SOX regulated environment
• Creation of computer systems validation documents (Validation Plans, Master Test Plans, Risk Assessments, Validation Summary Reports, etc.)
• Development of all associated documents (IQ, OQ, PQ) for GAMP-based validation of quality computer systems
• Documentation of validation test results and systems regulations (21 CFR Part 11, GxP etc)
• Understanding of Software Development Lifecycle Practices
• Capable of working independently and within a team
• Strong communication and documentation abilities and very strong Word and excel.
Excellent written and verbal communication skills and critical thinking abilities are a must
Please note this is a possible temp to perm position Candidates should be interested in perm positions
SAP Validation experience highly preferred
Computer System Validation experience a must
ADVthanksANCE,
Vikas Jain
Bitsoft International, Inc.
2272 W. 95th St., Suite 220
Naperville, Illinois 60564
Tel: (630) 364-1839
Fax: (630) 596-9069
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