Lead Auditor BA/BE

6 days ago

Ahmedabad, India Veeda Clinical Research Limited Full time

About the Role

Responsible for overseeing the auditing processes related to Bioavailability/Bioequivalence (BA/BE) studies and operations. Ensures compliance with Good Clinical Practice (GCP), applicable regulatory guidelines, including FDA, EMA, and other international standards. The Lead Auditor collaborates with cross-functional teams to maintain high-quality standards in BA/BE studies


Responsibilities

  • Plan, schedule, and conduct internal audits related to BA/BE activities.
  • Perform risk-based audits of clinical, bioanalytical, and supporting operations within the organization.
  • Ensure compliance with protocols, SOPs, regulatory requirements (FDA, EMA, etc.), and quality standards.
  • Conduct external vendor and site audits as needed for clinical and bioanalytical operations.
  • Ensure adherence to GCP, GLP, and other applicable regulations.
  • Keep abreast of current regulatory trends and updates in BA/BE and bioanalytical guidelines.
  • Identify audit findings, root causes, and areas of non-compliance.
  • Work with internal teams to develop and monitor corrective and preventive actions (CAPA) to resolve audit findings.
  • Track and ensure timely closure of CAPA, verifying the effectiveness of implemented actions.
  • Prepare comprehensive audit reports, including detailed findings, observations, and recommendations.
  • Maintain records of all audit activities in accordance with regulatory and organizational requirements.
  • Ensure documentation is accurate, up-to-date, and available for internal and external audits or inspections.
  • Perform qualification audits of CRO vendors, clinical sites, and laboratories involved in BA/BE and studies.
  • Evaluate vendor compliance with applicable quality and regulatory standards.


Qualifications

B. Pharm / M. Pharm / M.Sc.

Experience

10 to 15 Years

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