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Device Design Control Specialist - Global Device Innovation & Development

Driven by its entrepreneurial spirit and a passion for science Ferring Pharmaceuticals is a biopharmaceutical company dedicated to the development of innovative treatments that make a real difference in people’s lives all over the world. Active in the areas of reproductive health, urology, gastroenterology and endocrinology, we develop medicine on the body's own terms. We believe in the power of people and research - and go where ideas and research take us to improve lives of our patients. 
 
Would you like to join us in a challenging position as design control specialist? We offer a challenging and exciting job in an international company with great development possibilities, an entrepreneurial and open work environment, where your contributions will be valuable and make a difference.

The team 
The Global Device Innovation & Development team is looking for a design control specialist, who will work in close cooperation with our device team and drug development group. The department has the responsibility from the first concept ideas to launch of delivery systems across all of the therapeutic areas. You will be part of a team playing a key role in planning and executing the design controlled documentation to support the Ferring development pipeline and commercial success. This also includes risk management ranging from planning and execution on risk management activities and deliverables. Our department is located in Ørestaden, Copenhagen and is part of the Global Device R&D function area in the Global Pharmaceutical Research & Development organization.  
 
The position
Your main focus is to work within the device development projects as responsible for the design controls from project initiation until successful design verification, validation and transfer. The position is an opportunity to contribute to the development and documentation aspects of the device part of drug delivery projects including responsibility for the risk management activities, as they move from project initiation to clinical studies, manufacturing, global submission and commercialization.  
All tasks will be carried out in close collaboration with the device project managers and other functions (RA, QA, CMC project leaders, etc.) and thus it is of importance that the candidate thrives by working in a cross functional environment and has a good understanding of the device and drug development processes. 
 
You are interested in writing, compiling and completing technical documentation and know the importance of ensuring that the Design History File is up-to-date.  
 
Your main responsibilities will be: 

  • Structure and execute on design documentation as defined in development plans for projects across therapeutic areas. This includes collaboration with external development partners 
  • Structure and execute risk management documentation (plan, analysis & summaries) 
  • Setup review for documentation and secure stakeholder involvement underway 
  • Administer documentation both outside Ferring and into own document management system 
  • Accountable for DHF maintenance during development phases 
  • Setup design reviews and support the device project manager in the execution of these 
  • Support the development QMS system maintenance and being responsible for the continuous maintenance of the development procedures   

Qualifications 
The ideal candidate: 

  • Holds a M.Sc. in a discipline relevant to design control engineering 
  • Minimum of 3 years of experience within the pharmaceutical/medical device industry 
  • Experience with design control, risk management, establishing- and maintenance of design history files 
  • Knowledge of CMC drug development and experience of GXP regulated work within the pharmaceutical industry is a plus

Your profile: 

  • You have a keen interest in drug delivery devices including the design control aspects 
  • You are motivated by facilitating new ideas and ways to work, by finding the essential elements in an often unpredicted development phase 
  • You are a strong communicator of ideas, direction and solutions and are able to navigate in an environment with many stakeholders 
  • You have a proven track record for successful design control and risk management execution 
  • You are fluent in English - spoken and written 

Furthermore you should be keen on working in a multicultural and interdisciplinary environment 
 
We offer 
A challenging and exciting job in an international company with great development possibilities, an entrepreneurial and open work environment, where your contributions will be valuable and make a difference.   
 
Additional information
For additional information, please contact Director, Global Device Innovation & Development Martin Pram at +45 8833 8834. Please send your application and CV as soon as possible and no later than 13th April 2018. 

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