Clinical QA Auditor

Orbit Pharmaceuticals; Gujarat; On-site; INR 1,500,000 - 2,300,000; Full time

Job summary

Orbit Pharmaceuticals in Gujarat, India seeks a Clinical QA Auditor to support Quality Assurance for clinical studies. You will ensure QMS compliance, plan and conduct internal and vendor audits, and review study protocols, ICFs, CRFs, and related documents.

Responsibilities include training on QA processes, managing SOPs, change controls, CAPA, and archival of QA records, while ensuring adherence to ICH-GCP, CDSCO regulations, and other applicable guidelines.

Qualifications

• 2-3 years of experience in Clinical Quality Assurance.
• B.Pharm., M.Pharm., M.Sc., or equivalent qualification.
• Well-versed in QMS for clinical studies.

Responsibilities

• Plan and conduct internal system audits (System audit) and Vendor audits (External audit).
• Review clinical study protocols, ICFs, CRFs and related documents.
• Plan and conduct in-process audits of study activities.
• Plan and conduct retrospective audits of QA documents and data.
• Review calibration and qualification/validation documents of instruments.
• Conduct SOP and QMS-related training programs as per schedule.
• Manage issuance, control, distribution, and maintenance of SOPs and QA documents.
• Archive and retrieve QA documents and ensure timely closure of QA observations.
• Review and track Change Control, Deviation and CAPA.
• Ensure compliance with ICH-GCP, CDSCO regulations and guidelines.

Skills

QMS requirements

SOPs & QA docs

Internal & Vendor audits

Protocols/ICFs/CRFs review

In-process audits

Retrospective data audits

Calibration/ Qualification docs

QA training programs

SOP/document management

QA document archival

QA observations closure

Change Control/Deviation/CAPA

ICH-GCP & CDSCO regulations

Education

B.Pharm./M.Pharm./M.Sc. or equivalent

Job description

Job Description

Position Title- Clinical QA Auditor

Department- Quality Assurance

Experience Requirement: 2-3 years of experience in Clinical Quality Assurance.

Qualification Requirement: B.Pharm., M.Pharm., M.Sc., 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 sufficient expertise in preparation and review of SOPs and other QMS related documents.
• 3.Plan and Conduct Internal audits (System audit) and Vendor audits (External audit).
• 4.Proficiency in Review of Clinical Study Protocols, Informed Consent Forms (ICFs), Case Record Forms (CRFs) and other protocol related documents.
• 5.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.
• 6.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.
• 7.Proficiency in Review of Calibration and Qualification/Validation documents of the instruments/equipments.
• 8.Conduct SOP and QMS-related training programs as per the approved training schedule.
• 9.Manage the issuance, control, distribution, and maintenance of SOPs, study-related documents, and other QMS documents.
• 10.Archival and retrieval of QA documents.
• 11.Compliance verification of QA observations and their timely closure.
• 12.Review and tracking of Change Control, Deviation and CAPA.
• 13.Good understanding of ICH-GCP, CDSCO regulations, and applicable regulatory guidelines.