What are the responsibilities and job description for the Deviation Investigation Writer position at Belmar Pharma Solutions?
POSITION OVERVIEW
This position is primarily responsible for supporting the Quality department as a deviation and/or investigation writer. The ideal candidate will have experience conducting root cause analysis investigations, determining appropriate corrective and preventive actions and defining effective check criteria. Additionally, the ideal candidate will have experience in a cGMP manufacturing environment.
RESPONSIBILITIES
Writing deviations within target timelines
Writing root cause investigations with target timelines
Defining corrective and preventive actions (CAPA) to prevent event recurrence
Writing effectiveness check acceptance criteria
Writing risk assessments
May support CAPA implementation activities through owning change controls, revising documents, or revising batch records
Writing effectiveness check acceptance criteria for investigations