As a Senior Quality Assurance Auditor, you will partner with internal stakeholders to oversee laboratory practices globally and ensure compliance with international standards. This role involves auditing activities to guarantee alignment with ISO 15189, College of American Pathology (CAP), Good Clinical Practices (GCP) and other relevant laboratory standards.
Key Responsibilities
* Develop and implement change management strategies to enhance laboratory processes.
* Assist with accreditation processes, particularly for the ISO 15189 Standards, by ensuring effective documentation and verification.
* Conduct follow-up on external inspections and verify completion of corrective actions to maintain the quality management system.
* Maintain the Quality Management System (QMS) in accordance with current ISO 15189 standards, CAP, GCP and other relevant laboratory standards.
* Support tasks related to the lab environment, including conducting internal audits against applicable laboratory standards.
* Participate in internal and external audits as required to ensure continuous improvement.
Requirements
* Experience as a Quality Assurance/Compliance Auditor is essential.
* Advantageous: Experience within a Laboratory or Clinical environment can be beneficial.
* Knowledge of ICH-GCP and relevant GxP regulations and guidelines is desirable.
* A BSc Degree is required.
* Strong communication and relationship management skills are necessary.