Experienced QA or RA professional with a strong drive - Denmark
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- 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.
- 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.
- 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.