Research Associate- LBC Quality Assurance
Lupin
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 Post Graduation in PharmacyWork 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
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