Auditor/ Research Associate- QA

Role & responsibilities:

1. To implement, manage and ensure the functions of GCP/ GLP Quality Assurance program that will assure all BA/BE studies and clinical studies to withstand regulatory scrutiny.

2. Assist to manage GCP/ GLP inspections of different regulatory bodies like USFDA, WHO, ANVISA etc. and second party sponsor audits.

3. Generation, distribution, retrieval and archival of SOPs of QCPL and maintenance of related records/logbooks/master list of SOPs.

4. Archiving the study and system related documents and electronic data generated at QCPL (As per OECD guidelines/ applicable regulatory guidelines/ current in house SOP).

5. Developing and implementing quality assurance plans for clinical and bioanalytical studies.

6. Conducting regular audits to ensure compliance with regulatory standards and protocols.

7. Reviewing of documentation related to clinical study, such as study protocols, case report forms, and consent forms etc.

8. Reviewing of documentation related to Bioanalytical study, such as method SOPs, Sample analysis plan etc.

9. Conduct the vendor or third party onsite and offsite audits.

10. Identifying non-compliance issues and report findings to the Head QA.

11. Training staff on quality assurance procedures and requirements.

12. Reviewing and evaluating corrective actions and preventive actions taken in response to audit findings.

13. Maintaining up-to-date knowledge on regulatory guidelines and standards.

14. Participating in the selection and qualification of clinical study sites (in case of clinical trial).

15. Conduct routine and non-routine audits of clinical research activities.

16. Develop and implement quality procedures, policies and protocols as per regulatory requirements.

17. Ensure all clinical trials and procedures are compliant with good clinical practices (GCP), applicable sops and guidelines.

18. Review and evaluate study data for consistency and accuracy.

19. Assist during regulatory and sponsor inspections or audits.

20. Assist in the preparation of regulatory submissions and report preparation.

21. Issuance, manage and control the documents.

22. Review and verification of audit trial for the software systems.

23. Review and verification of time synchronization of instruments and equipment.

24. Verification of facility compliance and ensure the readiness of facility to conduct studies.

25. Issuance of Quality Statement on behalf of CRO to sponsor.

26. Generation, distribution, retrieval and archival of SOPs and maintenance of related records/logbooks/master list of SOPs.

27. Conducting in process and retrospective audits for various phases of the clinical and bioanalytical studies, etc.

28. Conducting system audits and issuance of audit report for various support departments such as human resource, engineering, information technology, project management, regulatory affairs, store etc. as per applicable SOPs.