Jobbet "Clinical & R&D QA Specialist" er udløbet.
Vis flere job i denne kategori
Vis mig flere job
Få de nyeste job i din indbakke
Opret en jobagent nu

We are looking for a QA Specialist to oversee the clinical and R&D microbiome area.

This is a unique chance to work within the novel microbiome area and impact the development of Medicinal products and dietary supplements in Chr. Hansen together with a team of dedicated scientists!

The microbiome field grows rapidly and as the world largest probiotic manufacturer, Chr. Hansen has a unique position to investigate the potential of using live microorganisms to improve health. We therefore explore our capabilities to produce viable probiotic bacteria for medicinal products and dietary supplements.

Your role
You will ensure that test material is produced according to clinical trial phase I-III GMP or dietary supplement requirements. You will support customers and partners in setting up clinical trials according to guidelines and legislation. The microbiome area is novel and you will need to navigate, balance and impact the current and emerging legislation to ensure compliance. You can have a significant impact on defining the microbiome foundation for the future. You will be the QA clinical (production and trial) and R&D anchor and work close together with Clinical R&D, Clinical Trial and Regulatory Affairs. 

Your primary tasks will be:

  • Define an appropriate framework for Clinical and R&D together with the stakeholders.
  • Review and approve SOP’s, records and documents to ensure compliance with relevant legislation.   
  • Ensure compliance of clinical trial setups, protocols and reports from trials as applicable. 
  • Define requirements for the relevant data systems. 
  • Provide QA guidance to partners and stakeholders. 
  • Work closely with partners, Regulatory Affairs, Medical Communication and CMO’s to assess the risks and benefits of projects and products.
  • Evaluate, investigate and approve complaints, deviations and other queries.
  • Participate in the development of relevant legislation and stay up to date with all related quality legislation and compliance issues.
  • Take on a leading role together with Regulatory Affairs for the preparation, conduct, and responses to Regulatory Agencies.

Strong experience with clinical trials, clinical R&D and good stakeholder managements skills

This is a very exciting position as legislation is still emerging and it will require full use of previous experience working within clinical production and clinical trials. As such you will also need the ability to read and interpret legislation and follow industry trends in a fast-evolving regulated environment.

Furthermore, you come with an educational background from natural science and minimum 4-5 years of experience within clinical trials, clinical production and R&D and is comfortable to set the QA direction in collaboration with stakeholders and be the responsible compliance person. Preferably, most of your career has been in the biotechnology or pharma environment.

Working as Clinical and R&D QA Specialist you must thrive in a dynamic setup where your broad knowledge helps you in delivering professional and effective solutions. This includes the ability to plan and prioritize the work and keep an overview of the processes.

Finally, as you will be working cross-organizational you will need ability to collaborate and create sustainable relationships - across cultural, professional and geographical borders. This takes very good communication skills in English, written and spoken. As such, you can transmit your personal enthusiasm to other people around you and ensure deliveries according to plans and deadlines. 

We offer
A challenging position in a global company with excellent opportunities for personal development. You will be part of a hard-working team of competent colleagues and have the opportunity to make a significant contribution to the future activities within quality assurance of Clinical Trials & R&D. 

In QA site Hørsholm we work with quality assurance in the early stages of culture production, which is the foundation of our bulk and final goods production worldwide. We place great demands on both employees and equipment throughout the processes, including packaging of our products so that the same high quality is achieved every time. Currently, the department consists of 4 dedicated employees, who is located at our headquarter in Hørsholm. 

Miscellaneous
Contact person - Kristian Byrialsen, HH QA Manager, Site Hørsholm phone: 2624 3346.

Please apply by clicking the link 'Ansøg'. Here you can also enter your details into our CV-bank.

Deadline for applications is Dec 28th 2018. 

Read more about working for Chr. Hansen at: www.chr-hansen.com/career. 

Please write in your application that you've seen the job at Jobfinder.