Talent.com
This job offer is not available in your country.
Quality Auditor

Quality Auditor

ALLSTARSITNagpur, Maharashtra, India
7 days ago
Job description

A Quality Auditor is responsible for ensuring that all aspects of Beaconcure Quality Management System adhere to regulatory standards and established quality guidelines. This role is crucial for maintaining the integrity of clinical trial data and protecting the safety of participants.

Key Responsibilities

  • Conducting / Host Audits : Perform internal and host external audits. These audits verify compliance with Good Clinical Practice (GCP) guidelines, Good Documentation Practices (GDP), company standard operating procedures (SOPs), and other relevant regulations. Write up an audit report and track findings.
  • Quality Management : Evaluate and help maintain the company's quality management system (QMS). This includes reviewing quality events, incidents, and complaints to identify root causes and recommend corrective and preventative actions (CAPAs).
  • Documentation and Reporting : Prepare detailed audit reports that document findings, non-conformities, and recommendations for improvement. Present these findings to senior management and work with various teams to ensure issues are resolved.
  • Regulatory Compliance : Stay up to date with all applicable regulations and guidelines from bodies like the FDA and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Ensure that these regulatory requirements are communicated and implemented across the organization.
  • Training : Ensure training compliance of quality assurance procedures, GXP guidelines (such as GCP), and the importance of a quality-focused approach.

Required Skills and Qualifications

  • Education and Experience : A bachelor's degree in a relevant field (e.g., life sciences, or information technology) or equivalent audit experience. The candidate should possess working knowledge of US FDA Good Clinical Practices (GCP), Internal Conference of Harmonization (ICH), Electronic Records; Electronic Signatures (21 CFR part 11) and EU
  • Annex 11, GDPR, or GAMP 5.

  • Analytical Skills : Strong analytical and problem-solving abilities are vital for identifying discrepancies, evaluating data, and drawing logical conclusions from audit findings.
  • Attention to Detail : The role demands a meticulous and detail-oriented approach to reviewing documents, data, and processes.
  • Communication : Excellent written and verbal communication skills are necessary to clearly articulate audit findings and work collaboratively with diverse teams and stakeholders.
  • Knowledge of Regulations : A thorough understanding of GCP, ICH guidelines, and other relevant clinical trial regulations is a fundamental requirement.
  • Certifications : Certifications from professional bodies, such as the American Society for Quality (ASQ), can be advantageous.
  • Create a job alert for this search

    Auditor • Nagpur, Maharashtra, India

    Related jobs
    • Promoted
    Internal Auditor

    Internal Auditor

    IFB Industries LtdIndia
    MAY 2025 CAs, 2024 pass-outs, or freshly qualified—if you're a CA with a flair for data analytics & internal audit, APPLY NOW and bring your number magic to life!. As our internal Auditor, you'll be...Show moreLast updated: 30+ days ago
    • Promoted
    Manager - Quality

    Manager - Quality

    ITW Automotive - India & SEAIndia
    About Us : ITW is a Fortune 500 diversified manufacturing company that was founded on innovation and expanded on the strength of its customer commitment. For over 100 years, ITW employees have kept a...Show moreLast updated: 21 days ago
    • Promoted
    Senior Auditor

    Senior Auditor

    ElevateIndia
    Company Overview Elevate LLC is a national platform built to partner with growth-focused accounting, tax and advisory firms. Our mission is to empower entrepreneurial firms and their leaders by prov...Show moreLast updated: 8 days ago
    • Promoted
    Sap Quality Management Consultant

    Sap Quality Management Consultant

    YASH TechnologiesIndia
    We are looking for an experienced SAP QM Consultant with strong exposure to S / 4HANA projects and a working overview of PP. The ideal candidate Should have 5+ years of experience in QM - S / 4 HANA Pro...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Auditor (IT), Internal Audit

    Senior Auditor (IT), Internal Audit

    Enphase EnergyIndia
    Enphase Energy is a global energy technology company and a leading provider of solar, battery, and electric vehicle charging products. Founded in 2006, our innovative microinverter technology revolu...Show moreLast updated: 9 days ago
    • Promoted
    Audit Associate

    Audit Associate

    IRIS Centre of Excellence - Indianagpur, maharashtra, in
    We are excited to announce a job opportunity at.If you are a dynamic professional with strong coordination skills, a passion for auditing, and a keen interest and experience in UK Auditing, we woul...Show moreLast updated: 29 days ago
    • Promoted
    SBG Industries - Internal Auditor

    SBG Industries - Internal Auditor

    SBG Industries Pvt LtdNagpur, India
    About Us : SBG is a fast-growing organization committed to operational excellence, compliance, and process efficiency.We are looking for a detail-oriented and proactiv...Show moreLast updated: 16 days ago
    • Promoted
    Senior Quality Engineer I [T500-20376]

    Senior Quality Engineer I [T500-20376]

    Marriott Tech AcceleratorIndia
    Marriott Tech Accelerator is part of Marriott International, a global leader in hospitality.American multinational company that operates a vast array of lodging brands, including hotels and residen...Show moreLast updated: 10 days ago
    • Promoted
    Senior Quality Engineer I [T500-20387]

    Senior Quality Engineer I [T500-20387]

    Marriott Tech AcceleratorIndia
    About Marrio Marriott Tech Accelerator is part of Marriott International, a global leader in hospitality.American multinational company that operates a vast array of lodging brands, including hotel...Show moreLast updated: 10 days ago
    • Promoted
    • New!
    ▷ High Salary! Senior Auditor (IT), Internal Audit

    ▷ High Salary! Senior Auditor (IT), Internal Audit

    Enphase EnergyIndia
    Enphase Energy is a global energy technology company and a leading provider of solar, battery, and electric vehicle charging products. Founded in 2006, our innovative microinverter technology revolu...Show moreLast updated: less than 1 hour ago
    • Promoted
    Quality Assurance Engineer

    Quality Assurance Engineer

    GoQuantNagpur, IN
    Job Description : QA Engineer (Paid).GoQuant is a financial technology company dedicated to providing high-performance trading solutions for digital assets. We empower professional traders and instit...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Quality Engineer

    Senior Quality Engineer

    Strategic Talent PartnerIndia
    Role : Senior QA Engineer with expertise in.Key Responsibilities : - Develop and implement test plans, strategies, and automation for. NET testing using industry-standard tools.Collaborate on test run...Show moreLast updated: 17 days ago
    • Promoted
    Internal Auditor

    Internal Auditor

    Bharat Forge LtdIndia
    Independently Perform Internal audit reviews of various areas of the company, assess controls over operational efficiencies, financial reliability and compliance with applicable directives, regulat...Show moreLast updated: 30+ days ago
    • Promoted
    Quality Control Director

    Quality Control Director

    Citrin Cooperman India LLPIndia
    Job Title : Director – Quality Control – Director.Citrin Cooperman is one of the largest accounting and consulting firms in the United States, and 4th among mid-Atlantic firms, with over 2,500 emplo...Show moreLast updated: 29 days ago
    • Promoted
    Quality Auditor

    Quality Auditor

    ALLSTARSITNagpur, IN
    Beaconcure Quality Management System adhere to regulatory standards and established quality guidelines.This role is crucial for maintaining the integrity of clinical trial data and protecting the s...Show moreLast updated: 7 days ago
    • Promoted
    • New!
    Quality Auditor [Apply Now]

    Quality Auditor [Apply Now]

    ALLSTARSITIndia
    A Quality Auditor is responsible for ensuring that all aspects of Beaconcure Quality Management System adhere to regulatory standards and established quality guidelines. This role is crucial for mai...Show moreLast updated: less than 1 hour ago
    • Promoted
    Compliance Auditor

    Compliance Auditor

    NES FircroftIndia
    Ever wanted to be the guardian of compliance and the enforcer of ethical standards?.Role Objective To conduct thorough audits of supplier activities, ensuring compliance with onboarding, statutory,...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Associate Quality Consultant

    Senior Associate Quality Consultant

    Infosys BPMIndia
    Greetings from Infosys BPM Ltd.We are looking for Quality and Process improvement Consultants to augment our capability in deploying Continuous improvement methodologies across industry domains and...Show moreLast updated: 30+ days ago
    • Promoted
    Quality Engineer

    Quality Engineer

    AsiteIndia
    Roles and Responsibilities : Candidates having very good logical and analytic abilities.Experience in manual testing of web-based applications. Analyze and clarification of requirements with a custom...Show moreLast updated: 30+ days ago
    • Promoted
    Manager (Audit Quality – Financial Services)

    Manager (Audit Quality – Financial Services)

    Career GuidelineIndia
    We’re Hiring – Manager (Audit Quality – Financial Services) ✨ Location : .Gurgaon / Noida / Mumbai / Bangalore / Chennai / Kochi / Kolkata / Ahmedabad / Pune / Hyderabad CTC : .CA (Chartered Accountant...Show moreLast updated: 8 days ago