Synapse Labs Pvt. Ltd. – Urgently Opening for Quality Assurance / Quality Control || Apply Now
Prashant Nikam : Head Quality Assurance at Synapse Labs Pvt Ltd
Synapse Labs Pvt Ltd. have opening for below position
Clinical Quality Assurance Auditor – Quality Assurance (BA/BE)
Experience: 2 to 10 years
Number of Positions: 10
Qualification: M. Pharm/ B. Pharm/ M.Sc
Responsibilities:
- 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.
Clinical Quality Reviewer (QC):
Experience: 2 to 10 years
Number of Positions: 8
Qualification: M. Pharm/ B. Pharm/ M. Sc.
Responsibilities:
- 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
