General role description

Quality Assurance (QA) Specialists help ensure that health and medical products or services meet strict quality and regulatory standards.

In CROs and industry settings such as pharmaceutical, biotechnology, and medical device companies, they oversee processes and documentation to maintain compliance with Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and other relevant regulations. 

This role is critical for safeguarding patient safety, data integrity, and regulatory approval.

Key responsibilities

• Keep track of and update important quality processes - like staff training, safety checks, and written procedures - to make sure the organisation meets both internal standards and government regulations
• Conduct internal audits and support external inspections and client audits, including follow-up on findings and implementation of corrective actions
• Review and approve key quality documents - such as reports on issues, proposed changes to processes, or risk assessments - to ensure they meet required standards
• Investigate problems with processes or products and work with teams to fix the root cause and prevent them from happening again
• Collaborate with clinical, manufacturing, or laboratory staff to ensure activities comply with standard operating procedures and quality standards
• Help deliver staff training, assess and approve new suppliers, and support projects that improve how the organisation maintains high quality standards.