特殊技能:Masters degree in Pharmacy, Chemistry, or a related field plus two years or Bachelors degree plus five progressive years of quality assurance experience. Must have at least two years of experience in each of the following 1. Defining quality control policies and control quality of pharmaceutical production operations; 2. Providing oversight to quality system elements to ensure compliance with regulatory expectations and pharmaceutical industry standards; 3. Writing, reviewing, and approving procedures SOPs, protocols, and reports pertaining to quality system elements affecting pharmaceutical product quality; 4. Conducting investigations of deviations, Out of Specification OOS, and complaints; 5. Coordinating the implementation of Corrective and Preventative Actions CAPAs for pharmaceutical laboratory and pharmaceutical production efforts; 6. Overseeing Change Control Systems for changes to systems, procedures, products, and processes for pharmaceutical manufacturing; and 7. Initiating and participating in continuous improvement initiatives for pharmaceutical production operations. Will accept any suitable combination of education, training, or experience.