Our client is a small to midsize Contract Research Organization (CRO) based in the UK, specialising in clinical research. They work with a wide range of clients across Europe and the US, providing them with end-to-end solutions for their clinical studies. As a company, they are committed to providing the highest quality of service to their clients and are looking for an experienced Quality Assurance Specialist to join their team.

As a QA Specialist, you will be responsible for supporting the development and maintenance of all written standards within the company, including policies, standard operating procedures (SOPs), work instructions, and associated forms. You will work closely with the Quality team and other departments to ensure that all written standards are in compliance with relevant regulations, guidelines, and industry best practices. Your role will be critical in ensuring that the company meets and exceeds the expectations of the clients and regulatory authorities.

An ideal candidate has detailed knowledge of the clinical research landscape across Europe and the US. You will have a proven track record of developing and maintaining written standards in a regulated environment, and you will be comfortable working with cross-functional teams. You will have excellent attention to detail, be able to work independently and as part of a team, and have strong communication and interpersonal skills. If you are passionate about quality and are looking for a challenging and rewarding role in a dynamic and growing company, then we would love to hear from you.

Essential skills and experience:

• Primary experience in the Clinical Research sector within GCP regulatory framework.
• Significant evidence of work experience across the quality assurance function.
• Understanding of the principles of ICH GCP and regulatory requirements.
• Experience with site and system audits.
• Process mapping and written standards development.
• Quality control methodologies, spot checks, auditing.
• Excellent oral and written communication in English.
• Excellent organisational skills and personal presentation.
• Experience working within a team environment under time and resource pressure.

Requirements:

• University degree in life sciences/pharmacy/nursing/biotechnology.
• A minimum oyearsars’ experience working in a GCP QA or Compliance role.
• Excellent computer and I-device skills.
• Ability to complete tasks in an accurate and timely manner.
• Excellent fluent spoken and written English language is essential.