Lead Auditor - Quality Assurance - Bioavailability/Bioequivalence

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