A propos de notre client :
Our client is one of the world's largest healthcare organizations, using innovative research to bring the best products to people all over the globe.
Description de l'annonce :
- Continuously updating and improving the EMEA Quality Systems (QS)
- Ensuring full compliance and coordination between marketing organization's and plant's quality systems across the region
- Liaising with Global QA to ensure continuous alignment of policies and procedures
- Keep QS updated to the latest ISO requirements and other standards and regulations
- Planning and executing the end to end compliance of ELC EMEA regional processes for the complete product life cycle
- Leading implementation of Regional Technical Platforms which should be aligned globally and deployed to ELC, manufacturing sites and marketing organizations
- Defining, implementing, and monitoring compliance to a regional QS in accordance with business process needs, ELC systems, and applicable regulations of every country in EMEA
-Defining a structure of strategic QS procedures in alignment with the Regional Quality Manual
- Partnering with all affected functions at the ELC and outside, in order to define and implement QSPs for all GXP business processes
- Introducing a revision and improvement system
- Continuously updating the learning process with external partners (regulatory bodies, customers) in order to satisfy their needs
Profil recherché :
Masters degree in Pharmacy, Chemistry, Biology, or Chemical Engineering
- At least seven years plant experience as a leader of a QA or Regulatory Affairs function in a pharmaceutical/consumer care product manufacturers
- Solid knowledge of the european GMP for "consumer care" and OTC products
- QP requirements
- Ideally experience in a governmental agency or proven track record of ongoing contact with regulators across EMEA
- Proven people management skills with track record of developing team members
- Communication and presentation skills (ability to translate complex statements into simply messages
Michael Page Contact :
Your application will be sent to Maurice Thornton (Zurich office), please quote the job reference KMTH33549.