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Clinical Quality Assurance Officer
3 weeks ago
**Job description**:
- Ensure that all processes contributing to the performance of a clinical trial are conducted properly.
- Troubleshoot clinical trials and activities.
- Manage and maintain databases for the quality system.
- Prepare and assist in preparing annual reports and quality trending reports.
- Report the status of the quality levels of staff, systems and production activities.
- Preside over improvement programs.
- Evaluate quality events, incidents, queries, and complaints.
- Keep up to date with all related quality legislation and compliance issues
- Compile and prepare materials for submission to regulatory agencies.
- Document internal regulatory processes.
- Ensure regulatory rules are communicated through corporate policies and procedures.
- Utilize guidance documents, international standards, or consensus standards and interpret for guidance.
- Ensure that investigator, vendor, facility and system audits are conducted.
- Communicate any critical compliance risks noted from these activities to senior management.
- Assume a lead role for the preparation, conduct, and responses to regulatory agency.
- Provide leadership and strategy in line with global strategic objectives.
**Qualification : Fresher / experienced**
Science background (Botany / Zoology/ **Microbiology**) is required.
**Job Types**: Full-time, Permanent
Pay: ₹15,000.00 - ₹16,000.00 per month
Schedule:
- Day shift
**Education**:
- Bachelor's (preferred)
**Experience**:
- total work: 1 year (preferred)
Work Location: In person
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