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Dan Wienczkowski, ACIR, CIR, CDR, CSSR, PRC posted a job: Associate Director - Validation - St. Joseph, MO - send resumes to dan.wienczkowski@rightthinginc.com "Title: Associate Director, Validation Location: St. Joseph, MO Responsibilities: - Responsible for managing personnel, budgets and projects relating to systems, process, cleaning and equipment validation in GXP relevant areas such as Operations, R&D, Marketing, etc. - Maintain comprehensive electronic data base for tracking compliance and qualification status of all critical GXP relevant equipment, systems and processes. - Responsible for implementing current trends in regulatory compliance for all validation procedures for equipment, systems and processes. - Author, implement and update the validation master plan (VMP) to assure compliance with regulatory and corporate requirements. - Provide support to Product and Engineering Departments in the selection, review, acquisition, and upgrade of production equipment to assure future IQ/OQ/PQs can be performed on equipment sourced. - Proficiency in ISPE , USDA , EU and FDA requirements for validation. - Performs all Company business in accordance with all regulations (e.g., EEO, FDA, etc.) and Company policy and procedures. - Demonstrated high ethical and professional standards with all business contacts in order to maintain BIVI's excellent reputation in the community. Requirements: - Masters degree in a scientific discipline or bioengineering. - 5+ years of experience in GMP validation field and 5 years of experience in leadership. - Ability to plan, schedule, organize, prioritize, and coordinate project activities. - Ability to function in a leadership role and within cross-functional teams. - Good knowledge of statistics, data bases, and quality principles. - Ability to analyze validation and production data to assess compliance with GMP requirements and/or troubleshoot compliance problems. - Must be self-motivated and of high integrity. Please email your resume to - dan.wienczkowski@rightthinginc.com http://www.candidatecare.com/srccsh/RTI.home?d=boehringeringelheim.candidatecare.com&&_sm_au_=iVV52FJrBHrbDbV6" |
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Tuesday, September 13, 2011
New job Associate Director - Validation - St. Joseph, MO - send resumes to dan.wienczkowski@rightthinginc.com
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Performs all Company business in accordance with all regulations (e.g., EEO, FDA, etc.) and Company policy and procedures. - Demonstrated high ethical and professional standards with all business contacts in order to maintain BIVI's excellent reputation in the communityautomateandvalidate
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