Atlanta , GA , United States
Will manage the total quality function of a plant to ensure adherence to and compliance with established company quality policies practices SOPs and federal regulations. The primary role is to manage the quality assurance department all associated office activities auditing staff QA Engineers and Supervisors for solid-dose and liquid manufacturing and packaging operations.
Monitor and promote Quality Awareness and Regulatory Compliance for the entire site. Participate in investigations of process deviations and assist in determining disposition for non-conforming bulk and finished product as well as packaged materials.
Direct support for the staff will be necessary in terms of monitoring planning and scheduling and tracking all the necessary office responsibilities to meet the business requirements. This position manages all functional day-to-day aspect of the Quality Assurance(QA)department to help ensure product quality and site compliance to FDA requirements. This includes supervision of QA personnel and systems.
Requirements: Minimum of 2 years experience in the pharmaceutical or similarly regulated industry preferably in a Quality Assurance or Validation related position. Knowledge of regulatory environment.
Strong oral and written communication skills. Excellent organizational skills. Proven decision-making ability. Proven personnel development ability. Good presentation skills.
• EDUCATION: BS or BA preferably with related technical background.