Quality Assurance Executive Clinical Research

Clinvigilant research Pvt. Ltd; Sarkhej; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Clinvigilant Research Pvt. Ltd in Gujarat is seeking a Quality Assurance Executive to ensure clinical research activities comply with GCP, regulatory standards and internal quality systems.

The role involves audits, QA process management, documentation, and CAPA implementation to support ongoing studies. Candidates should have 3+ years in Clinical Research QA, strong regulatory knowledge, and excellent communication and organisational skills.

Qualifications

• 3+ years of experience in Clinical Research Quality Assurance.
• 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 meet GCP and internal policies.
• QA activities: develop, implement, and manage QA processes.
• Audits and inspections: plan, conduct audits and assist in prep.
• Documentation & reporting: prepare quality reports and maintain QA databases.
• SOP management: review and approve SOPs and ensure compliance.
• Training: identify training needs and coordinate staff training.
• Incident & quality event management: evaluate events and implement CAPA.
• Clinical operations support: assist with audit prep and study records.

Skills

GCP knowledge

Interpersonal skills

Analytical skills

Communication skills

Documentation skills

SOP development

Database management

Job description

About the Company

Clinvigilant Research Pvt. Ltd is a clinical research organisation focused on delivering high-quality clinical research services while maintaining strict regulatory compliance and ethical standards. The organisation supports clinical trials through robust quality systems, operational excellence, and adherence to global regulatory guidelines.

Role Summary

The Quality Assurance Executive will ensure 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.

Key Responsibilities

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 organisation.

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 organisational and database management skills.

Note: Candidates who are from the pharma industry and Ayurved industry, please do not apply.