Monday, December 2, 2013

Validation Consultant

6-8 months
Waltham, MA (US)
 
• Knowledge /Experience in FDA regulated environment with good understanding of cGxP standards
• Computer system validation
• Software Development Lifecycle (SDLC) and Software Test Lifecycle (STLC)
• QA Methodologies, Compliance project deployment from conception to implementation,
• Various FDA standards (21 CFR Part 11, 210, 211, 820),
• Creation/maintenance & implementation of SOPs
• Knowledge of FDA guidance’s and industry standards (i.e., GAMP)
 

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