Job description - Quality Assurance Officer
Alternative job titles
Clinical Quality Officer
Quality Officer
Quality Assurance Associate
Description
The Quality Assurance Officer ensures that all processes contributing to the performance of a clinical trial are conducted in accordance with ICH guidelines and other regulations. He/she is responsible for all activities involving quality assurance, and compliance with applicable regulatory requirements. The focus of the position is to develop, perform and manage all quality assurance related activities such as internal auditing.
Qualifications
For a candidate for quality assurance officer, a degree in science or a related field is often required; furthermore, candidates for this position often have a pharmacy degree. The candidate should possess knowledge of GCP, GMP, GLP, and ISO regulations.
Competencies
- Open and clear communicator
- Careful planning to achieve accurate and timely results
- Focus on quality and detail
- Maintain consistent output following rules and regulations
- Work together with others to realise goals.
Tasks
- Involved in all new QA Clinical activities and in all Clinical QA related trouble shooting
- Manages and maintains data bases for the quality system and prepares/assists in preparation of annual reports and quality trending reports
- Reports the status of the quality levels of staff, systems and production activities and participates in improvement programs
- Participates in the evaluation of quality events, incidents and possible complaints and the follow-up activities in the GMP departments
- Keep up to date with all related quality legislation and compliance issues
Back