The person in this role will be responsible for leading the design and implementation of Just-In-Time (JIT) training concept. The person will advise Pharma Medical Affairs on JIT training implementation and support Global GxP Director on training management and operations (incl assignments and training compliance monitoring). The person will be responsible for providing ad-hoc support to key projects (namely GEMS rollout, HCP Experience).
Senior Quality Expert / Compliance Lead
A global pharma company
Are you looking to work in a global growth company where you can make a real difference? Then you are right with us!
PhD or Msc in Science
As per industry
Scientific qualification (PhD, MSc or Bachelor’s Degree) in an appropriate scientific discipline or quality-related field with an in-depth knowledge of the international pharmaceutical product development process is needed. A minimum of 4 years’ experience with GxP requirements, quality management system including risk management and regulatory requirements from main Heath Authorities is must have. The candidate must have expertise in the principles and practices of Quality Risk management and / or GxP audits. A broad understanding of Quality Management, GCP / GVP and Risk Management processes is required along with a broad understanding of main Health Authorities standards (e.g. FDA, EMEA) and ICH regulations and guidelines.Pharma experience and FDA knowledge is an advantage.
Englisch: Sehr gut
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