Executive - Clinical QC

Job Description

Position Title- Clinical QC

Department- Clinical Affairs

Experience Requirement: 5-6 years of experience in monitoring clinical activities.

Qualification Requirement: B.Pharm., M.Pharm., MSc. or an equivalent qualification in a relevant scientific discipline.

Profile Requirements:

1. Perform QC review of clinical study documents and records as per approved protocol and procedures.

2. Review clinical study records for ALCOA+ principles, data integrity, and proper documentation practices.

3. Verify that study activities are performed in accordance with the approved protocol, amendments, SOPs, and applicable regulatory requirements.

4. Conduct QC checks of critical study activities and records, including Informed Consent, Participant screening and eligibility records, Dosing, Sample Collection and Processing, Safety and Adverse Event, Investigational Product related documents, Protocol deviations etc.

5. Verify consistency between source documents, CRFs/eCRFs, laboratory records, and other relevant study records.

6. Review electronic systems and applicable audit trails.

7. Identify missing, inconsistent, erroneous, or potentially unreliable data and ensure appropriate escalation and resolution.

8. Document identified discrepancies, observations, and QC findings in accordance with established procedures.

9. Communicate critical or significant quality issues to the appropriate personnel without undue delay.

10. Track responses, corrections, CAPA, and resolution of identified findings. Verify implementation and effectiveness of corrective actions.

11. Support risk-based quality oversight by focusing QC activities on critical processes and data.

12. Participate in periodic review of QC metrics, trends, and quality indicators

13. Support investigation of discrepancies, deviations, data integrity concerns, and other quality events.

14. Maintain awareness of applicable requirements, including ICH-GCP, NDCTR 2019, applicable CDSCO requirements, and other relevant regulations/guidelines.

15. Support implementation of changes arising from regulatory updates, revised SOPs, and quality-system improvements.

16. Support QA during internal audits, sponsor audits, regulatory inspections, and vendor audits, as required.

17. Participate in training on SOPs, protocols, systems, and applicable regulatory requirements.

18. Identify opportunities for process improvement and prevention of recurring quality issues.