Quality Auditor

4 weeks ago

Delhi, 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 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.

  • Quality Auditor

    1 week ago

    Delhi, India Voizworks Full time

    We are looking for Quality Auditor - New Delhi location Minimum Educational Qualification: - Graduate Minimum Relevant Work Experience: - 2 Years and above as Quality Auditor Job Description: Quality Auditor Objective: Quality Auditor (QA) performs a range of tasks depending on the type of team he/she leads. Major tasks are to Monitor transactions,...

  • Quality Auditor

    7 days ago

    Delhi, Delhi, India GMax Full time

    **Education**: Bachelor’s degree (any specialisation) **Location **:Chattarpur, Delhi **Timings**: 10 am to 7 pm **Experience**: 1-2 years of experience in a quality auditor role The Quality Auditor will be responsible for evaluating and ensuring the quality of customer service calls, providing feedback to improve performance, and ensuring compliance...

  • IATF Auditor

    1 week ago

    Delhi, NCR, Noida, India Quality Austria Central Asia (QACA) Full time ₹ 8,00,000 - ₹ 12,00,000 per year

    You must be an Internal Auditor in 9,14 & 45 An IATF 16949 auditor's primary role is to assess and verify an organization's compliance with the requirements of the IATF 16949 standard, a quality management system (QMS) for the automotive industry

  • Quality Auditor

    1 week ago

    Delhi, Delhi, India Devriz Fashion Lifestyle Private Limited Full time

    **Job Title**: Quality Auditor - Telesales **Location**: Preet Vihar, Delhi **Salary**: Up to ₹25,000 per month **Job Summary**: **Key Responsibilities**: - Monitor, evaluate, and audit telesales calls to ensure quality, compliance, and performance standards. - Provide regular feedback to telesales executives and suggest improvements. - Identify...

  • Quality Auditor

    7 days ago

    Azadpur, Delhi, Delhi, India ESSVEE SERVICES Full time

    **We are looking for a competitive and trustworthy, Quality Analyst to help us build up our business activities.**: - **Location: Azadpur/ Netaji Subhash Place, Delhi**: - **Shift Timing: - 9:00 AM TO 6:00 PM**: - **Salary - 20k**: - **Experience - 1 years to 4 years** **Key Responsibilities** ** **Key Responsibilities* - **Maintain working knowledge of...

  • Quality Auditor

    2 weeks ago

    New Delhi, India RCPC Full time

    Qualification - B.Tech./M.Tech. Civil Experience - 8 yrs in construction industry To Perform Quality Audit and coordinate with site team. Core standards of Quality, Environment and Health & Safety (ISO 9001, ISO 14001 and ISO 45001). Auditor qualification in IS 9001:2015 is also desirable. Knowledge regarding QA/QC Engg documentation and duties. Review...

  • Quality Auditor

    5 days ago

    Delhi, 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...

  • Quality Assurance Auditor

    7 days ago

    Delhi, 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

    5 days ago

    Delhi, 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

    6 days ago

    Delhi, 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...