Beschreibung
Tasks & ResponsibilitiesLead design and implementation of “Just-In-Time (JIT)” training concept for OMA
Operate and monitor execution of JIT training
Advise Pharma Medical Affairs on JIT training implementation
Support OMA Global GxP Director on training management and operations (incl assignments and training compliance monitoring)
Provide ad-hoc support to key projects (namely GEMS rollout, HCP Experience)
Must Haves
Minimum: 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
A minimum of 2 years’ 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
Pharma experience
FDA Knowledge is an Advantage
Should be familiar with Quality management, Risk management, documentations in a compliant way, should be hands-on
Strong analytical and planning skills
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.
Fluent in written and spoken English. Strong and confident communicator both internally at all levels and externally with outside and industry bodies.