再鼎医药（上海）有限公司新闻资讯

1) Responsible to execute the design, implementation, and maintenance of an effective Clinical & Good Clinical Laboratory Practice (GcLP) Quality Management System (QMS) by working with multiple functions, to support clinic, data management, biometrics, PK/PD, central labs and other related functions. 

2) Host for all regulatory inspections in the area of GCP and GcLP and work with related functions on the inspection response and follow up. 

3) Plan and conduct External Service Provider audits following GCP and GcLP related regulations. 

4) Plan and conduct the External Service Provider (ESP) Due Diligence and continuous assessment. 

 1) Support to maintain, improve, and implement GCP&GcLP QMS, including but not limited to: ? Create, review, revise control documents according to regulatory requirements and pharmaceutical industry guidelines such as ICH guidelines, etc; ? Ensure roles and responsibilities clearly defined in all sub-functional activities and specified in control documents; ? Ensure proper records and documentation management; ? Coordinate and manage deviations, change controls, CAPAs and effectiveness verification 

2) Host regulatory agency inspections and provide responses to inspection report findings after discussion with related functions 

3) Lead and oversee the training program and collaborate with function teams to ensure staff training is current as required by their role. Conduct GCP and GcLP training at least annually and serve as mentor to junior team members 

4) Review and approve computer system validation (CSV) documents to ensure compliance with regulatory requirements 5) Plan and conduct regular and vendor audits to assure that all clinical lab vendors activities are in compliance with the SOPs, study protocol, relevant regulations and guidelines; 

6) Plan and conduct lab vendor qualification assessment, inspection readiness and related QA activities about study process. 

7) Perform quality system audits if required; Track and trend audit findings, investigations, assess compliance risk.  

任职要求： 

1) Bachelor’s degree or equivalent in medical or pharmacy or a life/biological science or quality-related field, or equivalent combination of education, training and experience; 

2) Minimum one years working experiences in QA/QC experiences or expert in GLP/and/orGcLP area. 

3) Prefer to be Familiar with Bio-analysis testing including LC-MS/MS, ADA and Nab method or Biomarher testing or CAP/ISO 15189 Certication; 

4) Previous experience in Clinical Laboratory QA experience, Quality Assurance auditing，and/or proven clinical research experience; 

5) Be Familiar with Computer System Validation including Validation Plan, IQ/OQ/PQ and reporting. 

6) Detailed knowledge of GcLP & GCPguidelines and relevant regulations; 

7) Communication and interpersonal skills, ability to liaise with project teams; 

8) Good understanding of drug development and clinical trial process.