Senior Quality Assurance Associate

Job Description:

We are seeking a Senior Quality Associate overseeing clinical studies. The role is crucial in ensuring compliance with policies and procedures, protocols, and applicable regulatory requirements for clinical studies.

Key Responsibilities:

- Assure that clinical studies meet internal and regulatory requirements.

- Coordinate audits and inspections, support analysis of findings, and ensure effective CAPA management within required timelines.

- Manage vendors and suppliers.

- Plan and conduct internal and external audits

- Perform Investigation, RCA, and CAPA completion of Quality Events and Deviations.

- Be the GCP and wider GxP subject matter expert relating to Clinical Trials

- Involvement with new validation activities and monitor that change control

- Equipment maintenance and calibration compliance checking requirements.

- Develop and deliver training programs to ensure staff is knowledgeable about quality standards and regulations.

Requirements:

- Bachelor's degree in a related discipline to clinical trials

- Minimum 3 years of experience within a QA or Clinical Research role in a pharmaceutical, biotechnology, and/or CRO environment. Investigational Site experience is preferred.

- Previous auditing experience is highly desirable, particularly aligned to GCP

- Experience with Root Cause Analysis and CAPA management.

- Experience with eQMS platforms.

- Solid understanding and working knowledge of GCP

- Experience or understanding of CSV would be desirable.

About Proclinical:

Proclinical is a leading recruiter in the life sciences sector, dedicated to pairing exceptional talent with top positions globally. Want to stay updated? Follow us and check out our website for live roles and updates www.proclinical.com