Deviation Investigation Manager

  • Posted 3 years ago

Responsibilities

  • Lead and manage the deviation team, and prioritize team’s work upon the load release schedule.
  • Review deviation investigation reports generated by members of the Deviation and Investigation team and provide supplemental support in deviation investigation as necessary. Deviation reports which include root cause analysis, product impact assessment, implementation of appropriate CAPA(s), etc.
  • Perform deviation investigation and ensure timely closure by the team.
  • Coach and train the team with regards to interacting with customers
  • Work with all departments to identify appropriate actions to facilitate deviation closure.
  • Work closely with QA operations team to support lot release, identify and communicate problematic deviations early at the weekly Lot Release meeting.
  • Work closely with Head of Operational Excellence to facilitate the implementation of initiatives across manufacturing team, and support continuous improvement programs (Hoshins) by providing data extracted from the records in the quality systems (DMS, TrackWise, LMS).
  • Work closely with Manufacturing Managers to aid the development and tracking of Manufacturing performance metrics and generate monthly reports.
  • Work closely with Program Management to facilitate customer meetings.
  • Train the team to advance their technical writing and investigation skills.

Requirements

  • A relevant degree in scientific discipline
  • Minimum 6 years experience in biotech or pharmaceutical manufacturing industry
  • Proficient in technical writing and FMEA experience
  • Good written and oral presentation
  • Good engaging skills with all levels
  • Team player
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