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.
Individual to be a focal point for managing the event process to assure timeliness in completion of effective and concise investigations. Provides daily, weekly and monthly reports on key performance indicators or metrics related to the process.
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.
Able to read, write, speak and understand English. 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. Able to work independently and be flexible to changing priorities. Strong personal computer skills. Must have excellent teamwork and organizational skills.
Education and/or Experience:
Bachelor's degree with experience in a technical or scientific (Pharmaceutical Manufacturing) discipline. Five plus years experience in the areas of GMP regulations. Previous auditing experience is a plus