Project Manager
Requirements:
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Bachelor's degree or higher in Chemistry, Life Science, Engineering or related subjects.
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5 to 10 years validation experience
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Good oral and written communication skills
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Strong attention to detail
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Understanding of current Good Manufacturing Practices
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Experience in pharmaceutical processing, process equipment, utilities and computer systems.
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Additional requirements necessary for PM Classification I, II, III
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Validation Specialist
Requirements:
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Bachelor's degree in an applied Science or equivalent education and work experience
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Basic understanding of utility and process equipment operation and/or 3 years of utility or equipment validation experience
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Good oral and written communication skills
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Strong attention to detail
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Understanding of current Good Manufacturing Practices
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Ability to understand direction, drawings, equipment specifications.
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Additional requirements necessary for VS Classification I, II, III, IV
Computer Validation Specialist
Requirements:
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Bachelor's degree in Computer Science or Information Technology or equivalent education and work experience
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Good oral and written communication skills
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Strong attention to detail
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Understanding of current Good Manufacturing Practices
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Expertise in databases for applications such as inventory control, LIMS, maintenance, training etc.
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Knowledge of User Requirements Specifications, Functional Requirements Specifications, System Design Documents and Traceability Matrices
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Additional requirements necessary for CVS Classification I, II, III
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Administrative Field Coordinator
Requirements:
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Bachelor's degree in an applied Science or equivalent education and work experience
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Proficiency with MS Word, MS Excel and MS Project
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Ability to create and manage database for tracking project deliverables
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Good oral and written communication skills
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Strong attention to detail
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Understanding of current Good Manufacturing Practices
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Additional requirements necessary for AFC Classification I, II
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