Ensure compliance with regulatory standards and company procedures.
Plan and conduct audits of facilities and processes.
Monitor corrective and preventative actions and maintain quality systems.
Review and update SOPs, assess suppliers, and provide training and guidance on quality matters.
Support inspections and prepare QA documentation to safeguard operations and drive continuous improvement.
Participate in the maintenance of the quality system and forecast, monitor and control the work volume within Quality Assurance Unit (QAU).
Plan and organise all activities within the QAU and communicate the audit outcome to relevant personnel and site management.
Requirements
Minimum 2 years’ experience in Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), or International Organisation for Standardization (ISO) environments.
Degree in a relevant natural science.
Understanding of national laws and relevant regulations and guidelines and SOPs and site related functions.
Proficient in written and spoken English.
Strong attention to detail, communication, problem-solving, and organisational skills.
Able to work independently and collaborate effectively in a team.
Proactive and decisive with a scientific background (desirable).