Responsibilities :
- Lead a team of Batch Record Reviewers performing the following activities : Execute the initiation and / or evaluate deviation(s), interview personnel, analyze root cause, assess impact, identify corrective / preventive actions, present to management and close investigations in the Quality Management System (QMS).
- The Reviewers in this role will be responsible for executing root cause investigations, owning / authoring deviations, driving continuous improvement efforts.
- They will also manage both minor and major investigations as relates to Batch Record reviews.
- Work on a team under a Senior Manager.
- Cell / Gene Therapy experience preferred.
- The Lead Reviewer will also be responsible for reporting to the client management on a weekly basis on review details, project progress and project metrics, as well as providing coaching and training for the staff reviewers.
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Lead a team of Batch Record Reviewers performing the following activities: Execute the initiation and/or evaluate deviation(s), interview personnel, analyze root cause, assess impact, identify corrective / preventive actions, present to management and close investigations in the Quality Management S...
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