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Experienced QA or RA professional with a strong drive - Denmark  

Company managed [?] Still accepting applications

Posted on : 04 April 2017

Project Description


Job Description
  •  Are you passionate about compliance and quality? 
  • Do you consider your skills top class?
  •  Do you enjoy helping people ensure quality?
  •  Are you open minded and robust?
  • Do you find motivation in a mix of routine and non-routine tasks for you to organise and influence? 
  • Read on perhaps you are the Senior R&D QA Professional we are looking for.
 

About the Department
  • The position is based in the Regulatory Affairs (RA) QA group within Research & Development Quality Assurance. We are responsible for Quality Assurance for RA.
  • The group comprises of 4 engaged and dedicated professionals and overall we are 20 employees in the area.
 


The position
  • As Senior QA Professional you will take an active role as QA for Regulatory Affairs in Headquarters.
  •  Our stakeholders’ primary quality standards are GXP and ISO9001/13485. 
  • The responsibilities of the group include review and approval of Standard Operating Procedures (SOP), handling of nonconformities, and change handling. 
  • The team also works with pre-print approval of secondary packaging material and you may be involved in the process of setting up secondary packaging material. 
  • Onboarding will include a structured introduction and training program.
  • The job offers good opportunities to identify and define tasks and activities that can influence the QMS and quality mindset within R&D. 
  • Quality improvement is one of our focus areas and QA is an active participant in defining and executing future improvement activities/projects.
  •  In this job you will interact with many other professionals and areas in our company, both in and outside Denmark.


 
Qualifications
  • You have a relevant academic degree (e.g. MSc. Engineering, MSc. Pharm or similar Master degree within Natural Sciences) with at least four years of relevant experience.
  •  It is an advantage if you have been in a QA job before and have experience with nonconformity handling, change handling, SOP reviews and/or the labeling process. 
  • Alternatively, you have a solid background within Regulatory Affairs and/or pharmaceutical R&D combined with a key interest to grow competences within Quality.
  • Experience from project participation/management will also be regarded as a plus. 
  • You communicate with confidence in both written and spoken English.
  • We are looking for an open minded person with an outgoing attitude, strong interpersonal and networking skills.
  •  You are detail oriented with a strong quality mind set but can also take a pragmatic approach to problem solving. 
  • You are a genuine team player, who can also work independently. 
  • Furthermore we would enjoy having a straightforward person with a good sense of humor in our team and department.



Working with us:
  • Your skills, dedication and ambition help us change lives for the better.
  •  In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.