 Conduct in process audit of the Bioanalytical phase of BA/BE studies

 Ensure loading and disposal of processed samples on to HPLC-audosampler as per

analytical sequence

 Perform ‘Document control and issuance’ activities for SOPs, forms, formats, log

books, study specific protocols, validation protocols, qualification protocols of all

departments of WPPL as and when required.

 Conduct internal study audit, system audits to ensure compliance with GCP/GLP,

Protocols, SOPs and applicable regulatory requirements.

 Review of generated raw data and respective clinical study report, abbreviated clinical

study report, CRFs, SERs, eCTD compilation, of clinical study as per the requirement.

 Prepare audit report to adhere with the guidelines, written procedures and regulatory

inspections.

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