Research Associate- LBC Quality Assurance

Long Description

• To conduct in- process audits / periodic system audits / facility audits in Clinical research department.
• Review Clinical/Clinical Data Management raw data (Retrospective Audits) of Clinical DepartmentTo verify the logbook and related equipment used for study.
• To prepare and generate the SOP's
• To check and verify the instrument calibration records
• To check the training records and its compliance
• Review of Protocols, TLFs and CSR of all inhoused /outsourced BA/BE studies in compliant to regulatory requirements and release of QA Authentication
• Ensure the archival of the data is done as per in-house SOP
• Hosting an external audits or a third party audit.
• Any other responsibilities assigned by Head Quality Assurance as per study requirement's

Education

Work Experience

• 3-5 Years of Experience in conducting QA Audits in Clinical department in a consistent manner to ensure that the facility is compliant with established procedures and applicable regulatory guidelines
• Good Knowledge on Review of calibration records of all instruments pertaining to Clinical Research department
• QA work Experience with good understanding on the Quality Management system process.
• Good Communication, Computer Skills