Beschreibung
Key Accountabilities1.Support Global Medical Affairs deviation management process by acting as Deviation Owner and leading the process of deviation investigation and documentation, following up on CAPA design and implementation.
Support Global Medical Affairs vendor qualification process for clinical and RWE services by acting as Relationship Lead, driving the qualification process and ensuring its appropriate documentation.
Act as a global expert for the countries on Medical Healthcheck process, metrics and related systems.
Ensure audit readiness of Governance and Compliance function in terms of process documentation, personal records etc.
Requirements:
Scientific qualification (PhD, MSc or Bachelor's Degree) in an appropriate scientific discipline or quality-related field
in-depth knowledge of the international pharmaceutical product development process
A minimum of 2 years' experience with GxP requirements, quality management system including risk management and regulatory requirements from main Health Authorities.
A broad understanding of main Health Authorities standards (e.g. FDA, EMEA) and ICH regulations and guidelines.
A broad understanding of Quality Management, GCP / GVP and Risk Management processes
Ideal prior experience: clinical and/or development QA
Language proficiency: fluent written and spoken English knowledge.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.