Sr. QA Auditor GCP

Bengaluru - India

Monthly Salary: Not Disclosed

Posted on: 12 hours ago

Vacancies: 1 Vacancy

Job Summary

Job Description Senior GCP Auditor (Updated)

Location: Bengaluru (Hybrid) Global travel up to 2040%

Essential Functions

Plan schedule conduct report and close audit activities across countries to assess compliance with GCP regulations customer requirements SOPs and study guidelines.

Audit Planning & Strategy

Perform risk assessments on GCP-relevant vendors; determine audit type (onsite/remote/paper) scope and audit frequency.

Audit Execution

Lead qualification routine and for-cause audits of:

- Site Management Organizations (SMOs)

- Ethics Committees/IRBs

- Investigator Sites

- CRO service providers

- Data Management and Biostatistics service providers

- Review of Clinical Study Reports (CSR) to ensure GCP compliance and data integrity.

Evaluate eClinical systems such as EDC CTMS eCOA eConsent and IRT for GCP relevance.

Evaluate compliance with ICH E6(R2/R3) applicable regulations SOPs and study protocols.

Document audit findings classify risks and prepare highquality audit reports.

Provide interpretation of GCP regulations guidelines compliance status and internal policies.

Consult with study teams and vendors on audit observations and CAPA expectations.

Manage Quality Issues as required.

Deliver GCP training and compliance guidance to cross-functional teams.

Review and approve RCA CAPA and Effectiveness Checks; track timely closure.

Provide GCP guidance during regulatory inspection preparation.

Host customer audits and regulatory inspections.

Maintain audit documentation and quality records in the eQMS; support the audit lifecycle.

Lead/support QA process improvement initiatives and mentor new QA staff.

Qualifications

Bachelors or Masters degree in Life Sciences Pharmacy or related field.

812 years of GCP QA/auditing experience including CRO SMO EC/IRB and investigator site audits.

Strong knowledge of ICH E6(R2/R3) global GCP regulations and CSR review practices.

Experience conducting global audits and leading vendor qualification activities.

Strong communication documentation analytical and riskbased decisionmaking skills.

IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements misrepresentations or material omissions during the recruitment process will result in immediate disqualification of your application or termination of employment if discovered later in accordance with applicable law. We appreciate your honesty and professionalism.

Required Experience:

Senior IC

Job Description Senior GCP Auditor (Updated)Location: Bengaluru (Hybrid) Global travel up to 2040%Essential Functions Plan schedule conduct report and close audit activities across countries to assess compliance with GCP regulations customer requirements SOPs and study guidelines.Audit Planning & ...