Jr. QA Auditor

10 hours ago


Ahmedabad, Gujarat, India Vitely Corp Pvt Ltd Full time ₹ 8,00,000 - ₹ 16,00,000 per year

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.

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