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Synapse Labs Pvt Ltd, Opening for Clinical Quality Assurance Auditor & Clinical Quality Reviewer (QC)
We at Synapse Labs Pvt Ltd. have opening for below position
Quality
Assurance (BA/BE):
1. Clinical Quality Assurance Auditor:
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.
2. Clinical Quality Reviewer (QC):
Experience: 2 to 10 years
Number of Positions: 8
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.
Develop, SOPs and documents in synapse labs.
Training of Executives & Research associates of QC 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.
Interested candidates; please share resume to
prashantnikam@synapselabs.com
