Position: Entry level

Job type: Full-time

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My client is looking for a highly motivated and detail-oriented individual to join our team as a Quality Assurance (QA) Associate focusing on clinical trials. While prior QA experience is not required, candidates with clinical trial experience will be given preference. As a QA Associate, you will play a vital role in ensuring compliance with regulatory requirements and maintaining the highest quality standards throughout our clinical trial processes.My Client is a small biopharmaceutical company with a critical focus on Neurology and Immunology.Responsibilities
  • Assist in the development and implementation of quality assurance procedures and processes specific to clinical trials
  • Collaborate with cross-functional teams to ensure adherence to standard operating procedures (SOPs), Good Clinical Practice (GCP) guidelines, and relevant regulations
  • Conduct internal audits and document findings to identify areas for improvement and ensure compliance with applicable quality standards
  • Support the preparation and execution of external audits and inspections, including providing necessary documentation and assisting in addressing any findings
  • Assist in the review and approval of study-related documents, such as protocols, informed consent forms, and study reports, to ensure accuracy and compliance with regulatory requirements
  • Participate in the development and delivery of training programs related to quality assurance and clinical trial processes
  • Monitor and evaluate ongoing clinical trials to identify potential risks or issues and recommend corrective actions
  • Assist in the development and maintenance of quality metrics and generate reports for management review
  • Stay updated on relevant regulatory changes and industry best practices to ensure compliance and drive continuous improvement in QA processes
Requirements
  • Bachelor’s degree in a scientific or healthcare-related field
  • Previous experience working in clinical trials is required; experience in a quality assurance role is a plus
  • Solid understanding of GCP guidelines and regulatory requirements for clinical trials
  • Strong attention to detail and excellent organizational skills
  • Effective communication and interpersonal skills, with the ability to work collaboratively in a cross-functional environment
  • Analytical mindset and problem-solving abilities
  • Proficiency in using Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
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Deadline: 25-05-2024

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