Required Research Associate - B.Pharm, M.Pharm, Msc

Synergen Bio has Excellent Job Opportunity

1. Position:

Research Associate

2. Department:

Quality Assurance(QA)

3. Qualification:

B.Pharm, M.Pharm, Msc

4. Experience:

01 to 03+ year's

5.No Vacancy: 02

6. Job Location: Pune.

7. Role & Responsibility:-

➤ Carry out in Process audit of various clinical phases of the bio studies 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.

Carry out retrospective audit of CRF data, Trial Master File.

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

➤ 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.

Review the CSR dispatch related activities.

Allotment of deviation reference number.

➤ Reporting of audit observation to Head-QA/Designee.

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.

➤ Updating index of archived and in-house stored documents.

➤ To check the Calibration and validation (DQ, IQ, OQ, PQ) records of equipment/instruments.

8. How to Apply:

Interested Candidate Share CV on careers@synergenbio.com

Note: Immediate joiner Preferred

Click Here For Details

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