Clinical QA Auditor

2 - 6 years

0 Lacs

Posted:4 days ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

As a Clinical QA Auditor, you will be responsible for planning, conducting, and managing internal audits (Study Inprocess & Retrospective, System Audit) and Vendor audits in compliance with ICH-GCP, Protocol, SOPs, and applicable GxP standards/regulations. Your role will involve preparing audit reports, reviewing SOPs, study protocols, and clinical study reports, as well as assessing responses to audit findings and negotiating suitable actions for resolution. You will also be involved in reviewing deviations and CAPA plans, ensuring their implementation and closure, assisting in preparing the facility for client/sponsor audits and regulatory inspections, and performing document reconciliation for both Project and Non-project related documents. Additionally, you will review equipment calibration/validation records to maintain quality standards. To excel in this role, you should possess strong written and verbal communication skills, along with excellent analytical and problem-solving abilities. Good computer skills are essential, and being self-motivated with the ability to effectively prioritize work tasks is crucial. The ideal candidate will have a background in Life Sciences (B.Sc/M.Sc/B.Pharm/M.Pharm) and at least 2-5 years of experience in GCP quality assurance audits. A comprehensive understanding of ICH-GCP, US and EU regulations, and applicable GxP standards/regulations is required to ensure compliance and quality in auditing processes.,

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