Executive/Sr.Manager- Clinical Quality Assurance

Confidential • India, gujarat • Posted June 29, 2026

Position Overview

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

Key Responsibilities:

  • 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...