Executive/Sr.Manager- Clinical Quality Assurance

Position : Executive/Sr.manager- Clinical Quality Assurance 
Location - Gujarat

Key Responsiblities:



Create, review, and implement QA SOPs, GSOPs, and global documents.


Collaborate with R&D stakeholders to develop operational SOPs.


Conduct audits of BA/BE studies (bioanalytical inprocess and retrospective).


Perform system, facility, and process audits.


Audit and qualify/requalify CROs, CSPs, and material suppliers.


Review study documents (protocols, method validation, raw data, reports) for compliance with guidelines and GDP.


Review PBPK/PBBM model reports.


Review SOPs, GSOPs, ATPs, and instrument qualification (IQ/OQ/PQ/DQ).


Review deviations, incidents, temporary changes, investigations, CAPAs, and change controls.


Prepare timely audit reports; escalate critical issues to senior management.


Supp...