Quality Auditor

2 days ago

bangalore, India ALLSTARSIT Full time

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 EUAnnex 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.

  • Quality Auditor

    2 weeks ago

    bangalore, India ALLSTARSIT Full time

    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...

  • Quality Assurance Auditor

    2 days ago

    bangalore, India K3-Innovations, Inc. Full time

    Job Title: Clinical Quality Compliance ManagerLocation: Bengaluru, Karnataka, IndiaReports To: QA/Compliance Director or Clinical Operations DirectorJob Summary:Clinical Site Auditor to ensure compliance and quality at Clinical Trial sites. You will conduct site audits, review documentation, and verify adherence to protocols, GCP, GLP and regulatory...

  • Quality Assurance Auditor

    20 hours ago

    bangalore, India K3-Innovations, Inc. Full time

    Job Title: Clinical Quality Compliance Manager Location: Bengaluru, Karnataka, India Reports To: QA/Compliance Director or Clinical Operations Director Job Summary: Clinical Site Auditor to ensure compliance and quality at Clinical Trial sites. You will conduct site audits, review documentation, and verify adherence to protocols, GCP, GLP and regulatory...

  • Senior Auditor, Originations Credit Quality Control

    4 weeks ago

    Bangalore, Karnataka, India Ocwen Financial Corporation Full time

    Job Category Risk Management POSITION SUMMARY The Senior Auditor reports to Team Leader Originations Credit Quality Control The team is responsible to review loans from an underwriter s perspective for Forward and Reverse Lending Pre and Post Funding and provide appropriate and timely feedback to the underwriter The position requires a thorough...

  • Group Internal Auditor

    4 weeks ago

    Bangalore, India ED&F Man Commodities Full time

    Role Overview We have an exciting opportunity for a Group Internal Auditor based in Bangalore, India. This role offers the chance to work in a global environment with ample developmental opportunities for those eager to showcase their skills in a fast-paced soft commodities sector. The Group Internal Audit (GIA) team provides independent and objective...

  • Staff Auditor

    2 weeks ago

    Bangalore, Karnataka, India Lowe's Full time

    About Lowe s Lowe s is a FORTUNE 100 home improvement company serving approximately 16 million customer transactions a week in the United States With total fiscal year 2024 sales of more than 83 billion Lowe s operates over 1 700 home improvement stores and employs approximately 300 000 associates Based in Mooresville N C Lowe s supports the...

  • Qa Auditor- Clinical

    4 days ago

    Bangalore, Karnataka, India Syngene International Full time

    Job Title QA Auditor- Clinical Job Location Bangalore About Syngene Syngene www syngeneintl com is an innovation-led contract research development and manufacturing organization offering integrated scientific services from early discovery to commercial supply At Syngene safety is at the heart of everything we do personally and professionally Syngene has...

  • Sox Compliance Auditor

    4 weeks ago

    Bangalore, Karnataka, India State Street Full time

    Officer 1 Auditor - SOX Compliance Program FCO The Financial Control Oversight FCO department is responsible for the execution of Sarbanes Oxley SOX program across the entire organization of State Street Key functions of this group include determining the material accounts business area locations and risks required to be addressed as part of the...

  • Group Internal Auditor

    4 weeks ago

    Bangalore Urban, India ED&F Man Commodities Full time

    Role OverviewWe have an exciting opportunity for a Group Internal Auditor based in Bangalore, India. This role offers the chance to work in a global environment with ample developmental opportunities for those eager to showcase their skills in a fast-paced soft commodities sector. The Group Internal Audit (GIA) team provides independent and objective...

  • Group Internal Auditor

    4 weeks ago

    Bangalore Urban, India ED&F Man Commodities Full time

    Role Overview We have an exciting opportunity for a Group Internal Auditor based in Bangalore, India. This role offers the chance to work in a global environment with ample developmental opportunities for those eager to showcase their skills in a fast-paced soft commodities sector. The Group Internal Audit (GIA) team provides independent and objective...