Review investigations for quality related events triggered through the manufacturing process. Provide feedback to the investigation writer on the quality of the report with emphasis on compliance to SOP’s and cGMP. Must be the subject matter expert in the auditing/investigative process and provide the necessary leadership to assure continuous improvement in the mitigation of events associated with the manufacturing process.
Independently lead Quality Engineering projects including identification of projects, definition of project scope, writing Change Controls, creating Engineering required documentation, and project tracking.
Review and approve Quality documents such as SOPs, Change Controls, and QTO protocols, GTRs, Engineering Drawings, Maintenance Work Requests/Work orders, Inspector Qualification/Re-qualification, and challenge group creation and maintenance.
Must have excellent verbal and written communication skills, sound judgment and analytical skills to enable assessment of risk. Resourceful, self-reliant, self-motivated and confident. Ability to work independently and be flexible to changing priorities. Strong personal computer skills. Must have excellent teamwork and organizational skills. Must have Science /Engineering background and demonstrated ability to manage and complete projects.
Education and/or Experience:
Bachelor's degree in Science/Engineering with experience in an engineering or scientific (pharmaceutical manufacturing) discipline. Five plus years experience in the areas of GMP regulations. Previous auditing experience is a plus.