Beschreibung
Senior Quality Expert GXP - 12 months contract - SwitzerlandA new opportunity has been created for a clinical / R&d expert to support medical affairs department in setting up process for compliance and governance.
Key Accountabilities
Lead design and implementation training concept for medical affairs projects
Operate and monitor execution of training
Advise internally on training implementation
Support OMA Global GxP Director on training management and operations (incl assignments and training compliance monitoring)
Provide ad-hoc support to other key projects
Professional and Technical Requirements:
Scientific qualification (PhD, MSc or Bachelor's Degree) in in an appropriate scientific discipline or quality-related field with an in-depth knowledge of the international pharmaceutical product development process
Prior experience with GxP requirements, quality management system including risk management and regulatory requirements from main Heath Authorities.
Expertise in the principles and practices of Quality Risk management and /or GxP audits
Able to understand and work with enterprise and functional systems & data
Experienced in implementing and deploying projects/ changes in an organization
A broad understanding of Quality Management, GCP / GVP and Risk Management processes
A broad understanding of main Health Authorities standards (e.g. FDA, EMEA) and ICH regulations and guidelines.
Proven self-starter with experience in building capabilities based on defined business needs across geography and functions.
Please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.