Long Description

Review at least 20% raw data/conduct in process audits in bioanalytical Laboratory
To check the final report for the in-vivo and in-vitro BE validation and study sample analysis
To conduct in process audits and system audits
To verify the logbook and related equipment used for validation and study sample analysis
To check and verify the instrument calibration records
To check the training records and its compliance
To prepare and generate the SOP’s
Ensure the archival of the data is done as per in-house SOP
Any other responsibilities as per project requirement’s
Review of protocols, study data and reports in compliant to regulatory requirements and release of QA Authentication
Hosting an external audits or a third party audit.

Education

Masters in Pharmacy

3-4 Years of Experience in conducting QA Audits in Bio- analytical 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 Bio- analytical Research department
QA work Experience with good understanding on the Quality Management system process.
Good Communication, Computer Skills