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Research Associate- LBC Quality Assurance

Research Associate- LBC Quality Assurance

Lupin

3 - 5 years

1 - 5 Lacs

Pune

Posted:2 months ago| Platform:

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Skills Required

QA Instrument calibration External audit Pharmacy QMS Clinical research Research Associate Head Quality Assurance Clinical data management Auditing

Work Mode

Work from Office

Job Type

Full Time

Job Description

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 SOPs 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 requirements Education Post Graduation in Pharmacy 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

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Research Associate- LBC Quality Assurance