Job Summary: Support role as reviewer for management of department owned controlled changes, deviations, CAPAs, PQRs as directed. Scope includes every aspect of pharmaceutical production, including regulatory agency requirements. Responsibilities: Provide resource for related technical and compliance information across the company. Responsible for maintaining compliance in the area of product quality complaint handling and for maintaining all aspects of the product quality complaint business process and ADE investigation for domestic and global pharmaceutical products, including: Receiving complaints Recording and maintaining complaints and documentation in tracking system Assessing compliance impact Initiating, coordinating and conduction investigations Proposing root cause and corrective action Reporting, closing and summarizing complaint events Tracking CAPAs from complaints Informing Quality & Compliance Director informed of serious compliance issues stemming from the process Perform ex-post facto review of batch records and specifications related to batch release, annual verification and problem resolution Requirements BS Biology, Chemistry or related field Minimum 3-5 years related industry experience in Quality Assurance Excellent computer skills, the ability to learn new software quickly and perform multi-tasks between multiple programs at once Excellent verbal and written communication skills. Labtech Specialty Staffing is a highly specialized staffing & recruiting firm that concentrates our efforts primarily on the placement of scientific professionals. We serve clients in a wide variety of industries including clinical, pharmaceutical, food & beverage and manufacturing. We have been in business for 18 years and have established a reputation for providing high-caliber candidates in the industries that we serve. Our client base is diverse and strong, and provides our candidates with a wide array of opportunities within multiple scientific disciplines.
North Kansas C...
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