职位详细信息

Overview Responsible for enforcing an efficient and compliant auditing program according to senior management-approved Quality Assurance Operating Plan and company SOPs (Standard Operating Procedures)， GxP (e.g. GCP， GLP， GMP， GPvP， GDP， etc.) and clinical trials regulations. Provides expertise on the design， implementation and development of GxP， systems， processes and procedures. May manage QA auditors’ team to ensure contracted and internal audits are performed， findings reported to management and/or clients， and corrective actions evaluated. May have responsibility to support specific operations such as: Clinical Pharmacology Unit Bioanalytical Laboratory Logistics GMP Pharmacy Computerised Systems Responsibilities Participates in the selection， hiring and training of new QA staff. May functionally manage 1-15 Auditors and/or manage other managers Leads QA auditors’ team by providing clear team / individual goals and expectations and ensuring that each member of the auditing staff understands her/his responsibility to know and follow all SOPs and corporate policies Contributes to the development and ensures implementation of the Quality Assurance operating plan Makes recommendations for and assist in the development of Quality Assurance policies， procedures and practices. Maintains awareness of new system implementations， Quality Assurance and technological advancements. Qualifications 7+ years experience with auditing， compliance， and SOP development required， 2 years experience direct management of staff. Compliance or auditing management experience required. Must have thorough understanding of GCP and EC and/or US regulations Understanding of all aspects of clinical research， including protocol development， CRF design， clinical trial management (including laboratory methodologies ad clinical examinations)， data management， statistical analysis， clinical study reports， and regulatory submissions preferred Read， write and speak fluent English;fluent in host country language required. Fluency in other languages is a plus. 职能类别： 药品生产/质量管理 关键字： QA 微信分享