Trialcraft Clinical Research Services Private Limited is a leading clinical research organization dedicated to providing high-quality and compliant clinical trial management solutions. With a robust team of professionals, Trialcraft specializes in executing clinical studies across various therapeutic areas, ensuring adherence to Good Clinical Practice (GCP) and regulatory standards. As we continue to expand our operations, we are seeking passionate individuals to join our team and contribute to delivering exceptional clinical research services.
Job Title: Quality Assurance Executive
Job Type: Full-time
Experience Level: Entry to Mid-level
Job Description
Trialcraft Clinical Research Services is excited to announce an opening for the position of Quality Assurance Executive. The ideal candidate will play a crucial role in maintaining and enhancing the quality standards of clinical trial activities. Below are the responsibilities and qualifications for this role:
Key Responsibilities:
- Conduct Investigative Site Audits to ensure compliance with Good Clinical Practice (GCP) and regulatory standards.
- Oversee quality and regulatory compliance for clinical trial activities, ensuring that all processes meet established guidelines.
- Manage sponsor audits and regulatory inspections, facilitating effective communication between the QA department and external sponsors.
- Ensure strong communication between sponsors and trial teams for effective information exchange and continuous improvement.
- Develop and execute Standard Operating Procedures (SOPs) in compliance with ICH GCP and other regulatory requirements.
- Implement and maintain an effective Quality Management System (QMS) within the organization.
Qualifications and Requirements:
- Candidates from any pharmaceutical background are encouraged to apply.
- 1-2 years of experience in Quality Assurance (QA) within the clinical research environment.
- Strong knowledge of regulatory guidelines (ICH/GCP).
- Experience in conducting site audits and handling sponsor and regulatory audits.
- Excellent verbal and written communication skills.
How to Apply
If you are a dedicated professional seeking to make a difference in clinical research quality assurance, we would love to hear from you! Please send your resume to hrtrialcraft@gmail.com.
