Job Description
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).
Revi...