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 controls.

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

- Support CAPA creation, execution, and verify adequacy.

- Provide or assist in training on guidelines, regulations, and SOPs.

📌 Executive/Sr.Manager- Clinical Quality Assurance (India)
🏢 Talental Consultings
📍 India