Beschreibung
Task:- The objective of the function is to provide continuous professional hands-on consultancy and expertise to Customer partner in Ufa during the qualification, validation and start-up phases of a new sterile department for our product (plans, protocols, execution and reports).
- A team player is needed, who can adapt easily to different cultural environments (project-partners in US, Germany, Belgium, Switzerland, Russia and Czech Republic)
- In alignment with Process Engineering, the function is responsible that the production process is correctly implemented.
- The whole set of activities should be managed in such a way that agreed timelines, under responsibility of our local partner, are followed. All these activities should lead to successful process validation and commercial batches after regulatory approval; strong project management skills are required.
- The function should make sure that all quality systems at the Ufa plant are according to Customers expectations and are operated consistently and in compliance with GMP.
- The function should support and train local QA and other functions to reach an acceptable level of proficiency in operating the quality systems
Requirements (Must have):
- Because of the international nature of the assignment, a strong, independent personality is required, dynamic and with a lot of drive; he/she must speak English and also Russian, and must be willing to integrate into a completely different culture. Speaking other languages like Dutch and/or German is an asset.
Beginn: 01.04.2014
Dauer: 31.12.2014
Branche: Medizin/Healthcare