Quality Assurance Executive

Clinvigilant Research Limited; Ahmedabad District; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Clinvigilant Research Limited, a fast-growing CRO in Ahmedabad, seeks a Quality Assurance Executive to ensure regulatory compliance, GCP adherence, and continuous quality improvement across clinical trials.

The role covers audits, QMS maintenance, SOP management, training, documentation, CAPA, and collaboration with clinical teams to uphold standards and prepare for inspections.

Qualifications

• Minimum 3 years of experience in Clinical Research Quality Assurance or related functions.
• Experience with clinical trial processes, regulatory compliance, and audit management.
• Hands-on experience with Quality Management Systems (QMS) in clinical research.

Responsibilities

• Regulatory Compliance: Ensure processes comply with GCP and regulatory guidelines.
• QA Activities: Develop, implement, and manage QA processes; maintain QMS.
• Audits and Inspections: Plan and conduct audits; assist in preparation for audits.
• Documentation & Reporting: Prepare quality reports and manage QA databases.
• SOP Management: Review and approve SOPs; ensure SOP compliance.
• Training & Development: Identify training needs and coordinate programs.
• Incident & Quality Event Management: Evaluate quality events and implement CAPAs.
• Clinical Operations Support: Support operations in maintaining quality standards.

Skills

GCP knowledge

Regulatory guidelines

Interpersonal skills

Analytical thinking

Documentation management

SOP development

Database management

Job description

About Clinvigilant Research

Clinvigilant Research is a fast-growing global Clinical Research Organization (CRO) offering end-to-end clinical trial services and integrated eClinical technology solutions. We partner with Pharmaceutical, Medical Device, Nutraceutical, Cosmetics, and Wellness companies to deliver compliant, efficient, and high-quality clinical research worldwide.

Role Summary

The Quality Assurance Executive will be responsible for ensuring that all clinical research activities comply with applicable regulatory requirements, Good Clinical Practice (GCP) guidelines, and internal quality standards. The role involves conducting audits, maintaining quality systems, supporting clinical operations, and ensuring continuous improvement in quality management processes.

Regulatory Compliance

• Ensure clinical research processes comply with regulatory guidelines, internal policies, and Good Clinical Practice (GCP).
• Communicate with regulatory agencies and prepare required documentation for submissions.

Quality Assurance Activities

• Develop, implement, and manage Quality Assurance (QA) processes within the organization.
• Maintain and monitor the Quality Management System (QMS).

Audits and Inspections

• Plan and conduct audits of investigators, vendors, facilities, and systems.
• Assist in preparation and coordination for internal and external audits.

Documentation & Reporting

• Prepare annual quality reports, quality trending reports, and QC review reports.
• Maintain and manage databases related to the quality management system.

SOP Management

• Review and approve Standard Operating Procedures (SOPs) and modifications to existing SOPs.
• Ensure SOP compliance across clinical research operations.

Training & Development

• Identify training needs and coordinate training programs for clinical research staff.
• Support onboarding and training of new employees on quality systems and compliance.

Incident & Quality Event Management

• Evaluate and manage quality events, incidents, queries, and complaints.
• Implement corrective and preventive actions (CAPA) where required.

Clinical Operations Support

• Support clinical research teams in maintaining quality standards.
• Assist with audit preparation and maintain enrollment and study-related records in databases.

Required Experience

• Minimum 3 years of experience in Clinical Research Quality Assurance or related functions.
• Experience with clinical trial processes, regulatory compliance, and audit management.
• Hands-on experience with Quality Management Systems (QMS) in clinical research.

Required Skills & Competencies

• Strong knowledge of Good Clinical Practice (GCP) and regulatory guidelines.
• Excellent interpersonal and communication skills.
• Strong analytical and problem-solving abilities.
• Ability to manage documentation, compliance processes, and audits effectively.
• Experience with SOP development, review, and implementation.
• Strong organizational and database management skills.