Quality Assurance(Clinical research)

Roles & Responsibilities:
• Ensure clinical processes comply with applicable regulatory guidelines and standards
• Develop, implement, and manage Quality Assurance (QA) activities
• Conduct audits of investigators, vendors, facilities, and clinical systems
• Prepare annual quality reports, trending reports, and QC review reports
• Coordinate training programs for new clinical research staff and assess training needs
• Manage and maintain Quality Management System (QMS) databases
• Support clinical research operations including audit preparation and enrollment data entry
• Review and approve new SOPs and modifications to existing SOPs
• Evaluate quality events, deviations, incidents, queries, and complaints
• Compile and prepare documentation for submission to regulatory agencies
• Develop, implement, and maintain an effective Quality Management System (QMS)

Qualification:
• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or related field

Experience:
• Prior experience in clinical research and Quality Assurance preferred

Skills:
• Strong knowledge of GCP and clinical regulatory requirements
• Experience in audits and compliance management
• Understanding of QMS development and maintenance
• Strong interpersonal and communication skills
• Good documentation and reporting skills
• Ability to handle regulatory submissions and quality evaluations
• Detail-oriented with strong analytical abilities

About the Organization:
GSC Technolabs Private Limited is a Gujarat-based organization located in Prahlad Nagar, Ahmedabad, offering professional services in the clinical and technology domain. The company focuses on maintaining high-quality standards and regulatory compliance in clinical research operations.