QA Auditor | Clinical Quality Assurance & GCP Audits | Bangalore
Company: Not Disclosed
Location: Bangalore, India
Job Type: Full-Time
Work Mode: On-site
Experience: Associate Level (2–5 Years Preferred)
Category: Quality Assurance / Clinical Research
Job Overview
We are hiring a QA Auditor to strengthen clinical quality assurance, regulatory compliance, and audit readiness across clinical research projects and systems.
This role is critical in ensuring adherence to ICH-GCP guidelines, SOPs, and regulatory requirements, while supporting clinical trial audits, vendor audits, and quality management systems (QMS).
If you want to build expertise in GCP audits, CAPA management, and clinical QA systems, this is a high-value role in the pharma and CRO industry.
Key Responsibilities
Clinical Audits & Compliance
Conduct audits of clinical trials, systems, processes, and vendors
Assess compliance with ICH-GCP, regulatory guidelines, and SOPs
Prepare detailed and unbiased audit reports
Quality Management & CAPA
Investigate SOP deviations, quality issues, and complaints
Perform root cause analysis (RCA)
Develop and implement Corrective and Preventive Actions (CAPA)
Regulatory Inspection Readiness
Support preparation for customer audits and regulatory inspections
Assist in hosting audits and ensuring compliance readiness
Maintain documentation for audit trails and regulatory reviews
SOP Development & Review
Prepare, review, and update Standard Operating Procedures (SOPs)
Ensure alignment with regulatory standards and internal quality systems
Quality Advisory & QMS Support
Provide QA consultancy to project teams on GCP and regulatory compliance
Support implementation and maintenance of Quality Management Systems (QMS)
Participate in continuous improvement initiatives and QA programs
Required Skills & Qualifications
Education
Graduate in Life Sciences / Pharmacy / Clinical Research / Healthcare
Experience
Experience in clinical quality assurance or audits
Hands-on experience in clinical trial audits and site investigator audits (preferred)
Technical Skills
Strong understanding of ICH-GCP, regulatory requirements, and SOPs
Knowledge of CAPA, root cause analysis, and quality systems
Familiarity with clinical trial processes and audit procedures
Core Competencies
High attention to detail and analytical thinking
Strong documentation and reporting skills
Excellent communication and stakeholder management
Ability to work independently and manage multiple audits
Problem-solving mindset with a compliance-driven approach
Perks & Benefits
Opportunity to work in clinical quality assurance and regulatory compliance
Exposure to global clinical trials and audit processes
Career growth in QA, pharmacovigilance, and regulatory affairs
Collaborative and quality-driven work environment
Involvement in high-impact compliance and inspection readiness activities
Compensation
Salary Range: Not disclosed (competitive based on experience and QA expertise)
About the Role
This QA Auditor role is ideal for professionals aiming to specialize in:
Clinical Quality Assurance (QA)
GCP Audits & Regulatory Compliance
CAPA & Quality Systems (QMS)
Clinical Trial Inspection Readiness
Pharma & CRO Quality Roles
Application Process
Apply through the company’s official careers portal or submit your updated CV via the relevant hiring channel.
Call to Action
If you want to become the gatekeeper of quality in clinical trials—ensuring compliance, accuracy, and patient safety—this role is your opportunity.
Step into a career where quality defines success in drug development.
Apply now and build expertise in clinical QA and audits. 🚀
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