Position: Clinical Quality Assurance Auditor

Organization: Synapse Labs Pvt Ltd. 

Experience: 2 to 10 years

Number of Positions: 10

Qualification: M. Pharm/ B. Pharm/ M. Sc.
 
Responsibility:

• Audits of the in-process phase in compliance to the Study Protocol, relevant In house SOPs, and regulatory requirement.
• Retrospective Audits of the raw data generated during the course of a study in compliance to Study protocol, Good Clinical Practices, in house SOPs and other relevant guidelines.

Audit of Study Reports.

• Develope Quality Assurance Systems, SOPs and documents in synapse labs.
• Training of Executives & Research associates of QA for carrying out inspections and audits. 
• Ensure the implementation of corrective actions on QA observations.
• Updating & reporting the audit status of projects to Head–QA. 
• Ensure training of QA SOPs to all employees.
• Ensure that all the Synapse Labs employees have undergone training with respect to their job description.
• Review of clinical and QA SOPs & ensure the system compliance. 
• Carry out system audit of in-house/ contracted facilities/ vendor audits.
• Verification of QA observations and preparation of authentication statement for the study reports.