Jr. QA Auditor

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Job Description- Jr QA Auditor

We are seeking a detail-oriented and quality-focused professional to support and strengthen our Quality Management System (QMS). The role involves reviewing documentation, coordinating trainings, ensuring compliance across processes, and supporting regulatory and sponsor audits.

Roles & Responsibilities

Documentation & QMS Oversight
Review Quality Management System documents, including Quality Manual, SOPs, and technical SOPs, for accuracy and compliance.
Issue, control, and maintain documents as per the Document Management System.
Review instrument qualification and calibration certificates, as well as computerized system validation (CSV) documents.
Ensure computerized systems used at any stage of analysis remain in a validated state and verify electronic data and audit trails.
Training Coordination
Act as the Training Coordinator and execute all training-related activities as required by the training software/system.
Conduct training sessions on QMS-related documents such as SOPs and Quality Policy.
Sample & Data Management
Ensure all procedures related to sample management—including sample receipt, pharmacy, and sample retention—are performed as per approved guidelines.
Review study/project documents such as protocols, raw data, reports, and STPs for adequacy and accuracy.
Quality Compliance & Audits
Plan and conduct system audits and study audits to verify adherence to approved procedures.
Review quality tools such as incidents, deviations, change controls, OOS, repeat analysis, and CAPA as per respective SOPs.
Participate in regulatory and sponsor audits and support timely preparation and submission of responses.