Roles & Responsibilities
• Plan and conduct clinical trial audits in compliance with ICH-GCP, regulatory guidelines, and internal SOPs
• Review and maintain Quality Management Systems (QMS) documentation and processes
• Lead CSV validation and qualification activities related to clinical systems
• Ensure audit and inspection readiness for sponsor, regulatory, and internal audits
• Manage sponsor interactions and audit responses effectively
• Identify compliance gaps and drive CAPA implementation
• Lead and mentor QA audit teams to meet project timelines
• Monitor audit timelines and ensure timely closure of audit findings
• Support continuous quality improvement initiatives across clinical operations
Qualification
• M.Sc / B.Pharm / M.Pharm / Other relevant life science qualifications
Experience
• 10 – 15 years of experience in Clinical QA, auditing, and compliance
Skills
• Regulatory guidelines and compliance requirements
• Clinical QMS and auditing practices
• CSV validation and qualification
• Audit and inspection readiness
• Team leadership and timeline management
• Sponsor handling and communication
About the Organisation
Cliantha Research is a globally recognized clinical research organization providing integrated clinical, bioanalytical, and regulatory services. The company is known for its strong quality culture, regulatory expertise, and commitment to delivering compliant and reliable clinical research solutions.
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