Gables Search Group Jackson Township, NJ, USA
The purpose of the Deviation Investigator, Manufacturing, is to serve as a primary investigator for the Operations Group to ensure timely and accurate completion of high-quality manufacturing investigations and implementation of subsequent corrective actions. This will be accomplished largely through leading and conducting appropriate root-cause analyses for events and authoring investigation reports related to compounding, filling, inspection, and packaging of sterile and non-sterile pharmaceutical products. Own, lead, and support prompt, thorough, and well-written investigations assuring that root cause evaluations are performed in compliance with cGMPs and associated SOPs. • Utilize technical writing strategies to ensure content is clear, concise, and complete. • Drives investigations to timely closure through collaborative efforts with Operations, Quality Assurance, Engineering, and other functional areas, as needed. • As needed, utilize investigational RCPS tools like 6M,...