Quality Assurance Auditor

3 weeks ago

india, IN 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 requirements.


Key Responsibilities:

  • Conduct audits of clinical research sites across phases I–IV.
  • Review CRFs, informed consent forms, and regulatory documents.
  • Identify and report audit findings; recommend corrective actions.
  • Support site staff with compliance guidance and training.
  • Prepare audit reports and follow up on CAPA implementation.


Qualifications:

  • Bachelor’s degree in life sciences, nursing, pharmacy, or related field.
  • 10-12 years of clinical research experience, with auditing and QA experience.
  • Knowledge of GCP, ICH guidelines, and FDA/EMA regulations.
  • Strong communication, analytical, and organizational skills.
  • Ability to travel is required.


Preferred:

  • Clinical Research or Quality Auditing certification (ACRP, SOCRA).
  • Experience with eTMF and EDC systems.
  • Experience auditing multi-center or global trials.


Working Conditions:

  • Up to 50% travel to clinical sites.
  • Combination of remote, and field work.
  • Flexible schedule to accommodate site audits.

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