Responsible for the initiation, investigation and completion of process deviations aimed at identification of root cause, and implementation of correct actions to prevent recurrence. The position is expected to work in a cGMP environment, have working knowledge of Biopharmaceutical manufacturing processes, the ability to manage multiple ongoing projects concurrently, have strong meeting facilitation and conflict resolution skills, a strong technical writing capability, be action oriented, and be compliant minded while performing investigations.
Main Responsibilities: Technical writing for the educated but uninformed reader, translate moderate to complex scientific events into a brief and cohesive report as a finished product. Accurately capture immediate actions and containment of the event Address comments from both internal and external clients on the compiled final report. Gather Data from various sources across the client site, perform of Root Cause Analysis to determine the mos...