Study Director Analytical Chemistry
CurrentStudy director for safety assessment (supporting) studies.Method development and validation for quantification of pharmaceutical, industrial- and agro-chemicals in various matrices. Study planning:Communicate with sponsor to obtain full details regarding the test article, background and program of the study. Study protocol:Responsible for the analytical setup or analytical support of a study protocol. Facilitate QA GLP review. Approval and distribution of the protocol and ammendments.Technical performance of the study:Monitoring of correct and efficient performance of the study with respect to costs. This includes the monitoring of correct use of validated methods/systems, qualified equipment/people. Timely report when such resources not available. Share all study requirements with technicians. Check for correct use of SOPs and evaluate deviations. Inform management as well as sponsor regarding all deviations or circumstances which will affect the quality or integrity of a study. GLP:Studies are performed under GLP. Therefore, maintain knowledge regarding guidelines and share these with people involved in studies. Communication with Quality Assurance and , where necessary, answer study findings. Interpretation, documentation of reporting of the study:Responsible for scientific and correct interpretation of raw data. Correct, efficient and timely presentation of such data in the final study report. Responsible for study reports where signed as approver.Archiving:Responsible for transfer of all study related data and material to archiving department.Representative:Represent the company to sponsors in such a manner that company interests will optimally be assured.
