
QA
Job Description
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.
Archiving and maintaining all documents received from various department of WPPL
BEC.
To carry out other responsibilities as and when assigned by the Head of Department or
designee.