Executive - Clinical QA Auditor

Novumgen; Vadodara; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Novumgen in Vadodara, India seeks a Clinical QA Auditor with 5-6 years of clinical quality assurance experience to ensure QMS compliance and drive quality across audits and document handling.

You will review protocols, ICFs/CRFs, manage QA documentation, and support regulatory inspections, CAPA, and change controls, aligning with ICH-GCP and CDSCO guidelines.

Qualifications

• 5-6 years of experience in Clinical Quality Assurance.
• B.Pharm., M.Pharm. or equivalent qualification in a relevant scientific discipline.

Responsibilities

• Quality Management System (QMS) compliance for clinical studies.
• Implement QbD into the system and identify Critical to Quality factors.
• Prepare and review SOPs and other QMS documents.
• Plan and conduct internal audits (system) and vendor audits (external).
• Review Clinical Study Protocols, ICFs, CRFs and related documents.
• Plan and conduct in-process audits of study activities (ICF, dose, sampling, safety, pharmacy).
• Perform retrospective audits of trial data and QA documents.
• Manage QA-related software tools and document management.
• Understand CSV processes and related documentation.
• Review calibration and qualification/validation docs of instruments/equipment.
• Conduct SOP and QMS training per schedule.

Skills

QMS for Clinical studies

QbD integration

SOPs review

Internal audits

Vendor audits

Protocol review

ICFs/CRFs review

In‑process audits

Retrospective audits

Study/conduction software

Document Management

CSV knowledge

Calibration/Validation docs

QA training

SOPs control

QA document archival

Observations closure

Change Control/Deviation/CAPA

Regulatory inspections hosting

Education

B.Pharm./M.Pharm. or equivalent

Tools

QMS software

Document Management Systems

Job description

Job Description

Position Title- Clinical QA Auditor

Department- Quality Assurance

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. 1. Should be well-versed in Quality Management System (QMS) requirements applicable for Clinical studies.
2. 2. Should have knowledge of implementation of QbD into the system and identification of the Critical to Quality factors.
3. 3. Should have sufficient expertise in preparation and review of SOPs and other QMS related documents.
4. 4. Plan and Conduct Internal audits (System audit) and Vendor audits (External audit).
5. 5. Proficiency in Review of Clinical Study Protocols, Informed Consent Forms (ICFs), Case Record Forms (CRFs) and other protocol related documents.
6. 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. 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. 8. Have knowledge of handling of different softwares associated with the Study conduction/Document Management/QMS.
9. 9. Should have knowledge about the CSV process and related documentation.
10. 10. Proficiency in Review of Calibration and Qualification/Validation documents of the instruments/equipments.
11. 11. Conduct SOP and QMS‑related training programs as per the approved training schedule.
12. 12. Manage the issuance, control, distribution, and maintenance of SOPs, study‑related documents, and other QMS documents.
13. 13. Archival and retrieval of QA documents.
14. 14. Compliance verification of QA observations and their timely closure.
15. 15. Review and tracking of Change Control, Deviation and CAPA.
16. 16. Hosting of Regulatory Inspections/Sponsor Audits.
17. 17. Organizing and Handling of Management Review Meetings and follow‑up of the resulting action items.
18. 18. Good understanding of ICH‑GCP, CDSCO regulations, and applicable regulatory guidelines.