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Ensure compliance with relevant SOP’s while gathering, analyzing and applying information from
internal and external sources in order to perform a risk assessment of the impact each process
deviation and complaint has on the product, process and patient health and safety.
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As part of the investigation, gather information from all necessary internal and external sources
in order to evaluate the impact of the deviation on previously manufacturing product, as well
as the risk to future operations.
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Leads and support investigations across Manufacturing, Packing and other departments to ensure
timely closure for each investigation and follow-up activities.
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Works with the functional areas to identify the most probably root cause(s) and determine
appropriate preventative and corrective actions.
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Trend and analyze product compliant investigation data and address appropriate as well as
liaison with production and quality.
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Work independently to comply with procedure driven guidelines relating to deviation and complaint investigations.
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Conduct interviews with site personnel to gather data for the deviation report.
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Perform as the lead in root cause problem-solving sessions.
