Synergen Hiring for Clinical Auditor positions B.Pharm/M.Pharm freshers and experienced.

Position: Clinical Auditor

Qualification: B.Pharm /M. Pharm

Experience: 0 to 1.5+ year's

Note: Immediate joiner preferred. 

Job Location: Shivajinagar, Wakadewadi Pune.

Responsibilities:

🔖Carry out in Process audit of various clinical phases of the biostudies as per Protocol, SOPS and applicable regulatory guidelines.

🔖Carry out retrospective audit of raw data and study report, e-CTD data of clinical phase.

🔖Ensure the implementation of corrective action on QA observation.

🔖Updating and reporting the audit status of project to head-QA/Incharge. 

🔖Providing training of GCP and regulatory requirements to all employees.

🔖Preparation and review of SOPs and ensure the system compliance. > Carry out system audit of in-house/contracted facility and vendor audit.

🔖Verification of QA observation and preparation of authentication statement for the study report.

🔖Generation, Distribution, reconciliation, Retrieval of project and non-project related documents.

🔖Preparation of periodic audit schedule.

🔖Review the CSR dispatch related activities.

🔖Allotment of deviation reference number.

🔖Issuances of change control form, allotment of change control number (CCN), verify completeness of change control form and Implementation of proposed changes.

🔖Reporting of audit observation to Head-QA/Incharge. Preparation and trend analysis of deviation report.

🔖Conduct and co-ordinate between trainer and trainee. 

🔖Update training activities according to the training schedule requirement from time to time. In-house storage and retrieval of project and non-project related documents.

🔖A Updating index of archived and in-house stored documents. Reconciliation of form issued for projects

🔖Review the draft Blood time point deviation PK sheet, Draft CRF and clinical study updates.

Interested Candidate Share CV on careers@synergenbio.com