Responsible for managing Quality System aspects of compounding pharmaceuticals for compliance within the facility. Operates the area as the supervisor over designated Quality Systems staff, coordinating day to day functions.
Responsibilities may include:
- The site manager will report to the Director of Quality Assurance.
- Manage, develop and lead 2-5 Quality System Specialists.
- Manage the internal audit and inspection readiness programs for site including coordination of regulatory (FDA) audits, and customer audits.
- Responsible for all activities related to the Batch Record Issuance/ Quality Document Administration/CAPA/Deviation/Investigation/Change Management Systems.
- Manage investigation/deviation activities by working with other departments to determine the possible causes of the deviation. Aid in the analysis of each of the possible causes in order to determine the true roo