Experience Requirement: 5-6 years of experience in Clinical Quality Assurance.
Qualification Requirement: B.Pharm., M.Pharm. or an equivalent qualification in a relevant scientific discipline.
Profile Requirements:
1. Should be well-versed in Quality Management System (QMS) requirements applicable for Clinical studies.
2. Should have knowledge of implementation of QbD into the system and identification of the Critical to Quality factors.
3. Should have sufficient expertise in preparation and review of SOPs and other QMS related documents.
4. Plan and Conduct Internal audits (System audit) and Vendor audits (External audit).
5. Proficiency in Review of Clinical Study Protocols, Informed Consent Forms (ICFs), Case Record Forms (CRFs) and other protocol related documents.
6. Plan and conduct In-process audit of study related activities like, ICF presentation, Check-in activities, dose administration, sample collection and processing, safety monitoring, pharmacy related activities etc.
7. Plan and conduct retrospective audits of study related raw data like informed consent forms, screening documents, case record forms,
trial master file, investigational product related documents, sample separation data, CSR etc.
8. Have knowledge of handling of different softwares associated with the Study conduction/Document Management/QMS.
9. Should have knowledge about the CSV process and related documentation.
10. Proficiency in Review of Calibration and Qualification/Validation documents of the instruments/equipments.
11. Conduct SOP and QMS-related training programs as per the approved training schedule.
12. Manage the issuance, control, distribution, and maintenance of SOPs, study-related documents, and other QMS documents.
13. Archival and retrieval of QA documents.
14. Compliance verification of QA observations and their timely closure.
15. Review and tracking of Change Control, Deviation and CAPA.
16. Hosting of Regulatory Inspections/Sponsor Audits.
17. Organizing and Handling of Management Review Meetings and follow-up of the resulting action items.
18. Valuable understanding of ICH-GCP, CDSCO regulations, and applicable regulatory guidelines.