US: Senior Quality Assurance Consultant

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Date: 14-Apr-2009

US: Senior Quality Assurance Consultant

Essential responsibilities include: * Experience in GxPs including GCPs, GLPs and/or GMPs. * Thorough understanding of ICH guidelines. * Conducting quality audits and developing subsequent preventive and corrective actions plans (CAPA). * Interfaces with client representative(s) and sub- contractors to achieve desired results. * Ability to translate applicable regulatory requirements into processes/procedures that meet the intent of organizational requirements, applicable regulations, and ISO Standards. * Drives operational development of the Quality Management System.

* The above expertise will be demonstrated by a minimum of 10 years of applicable work experience. * Bachelor's degree in engineering or health-related field. * Knowledge of FDA and ICH regulations expected, knowledge of foreign directive (e.g., European, Canadian) desired. * RAC, CQE, CQA or similar regulatory or quality certifications preferred. * Excellent oral and written communication skills. * Attention to detail and follow through. * Ability to travel.

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BioTech FYI Center
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