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  • Location: Frankfurt (Oder)
  • Salary: Around €70,000 + 15% Bonus + Benefits
  • Job Type:Permanent

Posted 19 days ago

  • Sector: Discovery & Translational, Quality
  • Contact: Admin Profile
  • Contact Email:
  • Contact Phone: 01403 216216
  • Start Date: 2023-09-03
  • Job Ref: V-49149
Are you fluent in Mandarin? Are you developing your career in QA, with a background in standards such as ISO17025 / ISO15189 / HTA, gained in medical / clinical / genomics wet labs? Do you have an education in molecular biology, biochemistry, genetics, biotechnology or similar, with a passion for Quality and an understanding of a medical laboratory / genomics environment? If so, this will be an excellent career opportunity.
This is a brand-new role, with an international leader in Genomics services with sites in China, USA, UK and other countries, who are about to build a new lab in Germany. In the next few weeks they are going to confirm their site, which is likely to be in Limburg but could potentially be in Frankfurt. Working alongside the Lab Managers, you will assist in setting up a state-of-the-art laboratorywhat an exciting opportunity!
You will have the chance to design a QMS for Germany from scratch, using an electronic eQMS system which is shared with the company’s other sites in China, UK and elsewhere. Communicating frequently with your partner sites (especially in Beijing), you will create, implement, manage and scale up the Quality processes to ensure that the lab is built on the foundation of excellent Quality standards.
You will be paid around €70,000 EUROs, plus 15% bonus (paid quarterly) and other benefits to discuss on application.
Your role will include:
  • Designing and managing an effective Quality framework for the new German lab, using the company’s other labs as a starting point while ensuring the eQMS is suitable for Germany
  • Supervising and implementing an effective quality audit plan
  • Organising and checking lab documents, in line with ISO17025 and ISO15189 regulations
  • Hosting audits and ensuring audit-readiness (Human Tissue Authority etc)
  • Overseeing qualification maintenance work
  • Ensuring exceptional standards for document control
  • Maintaining and updating SOPs, experimental records, QMS documents, change controls and health & safety documents
  • Carrying out equipment calibration according to ISO and GCLP requirements, ensuring that key equipment has been calibrated according to schedules.
  • Reviewing and updating personnel training plans, carrying out staff training and carrying out quarterly competency assessments
  • Ensuring that external documents are distributed and controlled according to processes, and the document status is completed before deadlines to ensure their validity
You will join a new lab which is currently made up of 2 people and will continue to expand to support the company’s global growth. The company has plans to expand the lab to over 30 people, so it is important to start with a strong Quality setup. As such, this will be a fantastic career opportunity, not only to be a part of a growing a cutting-edge genomics business but also to develop your skills in QMS maintenance, document control, training, audit-readiness and continuous improvement.
Skills and Experience Required:
We are looking for an adaptable, energetic, collaborative, honest and versatile person to join this pioneering company who are developing new approaches to genomic research.
  • Life science qualification – ideally a degree minimum (preferably a Masters or PhD) in molecular biology, biochemistry, genetics, biotechnology or similar
  • A passion for Quality and developing QA / QMS processes
  • A knowledge of ISO17025 and / or ISO15189. Other knowledge such as GMP will be highly desirable
  • Fluency in Mandarin, ideally with strong German and English
  • Experience in using Laboratory Information Management Systems (LIMS) and / or a Linux system would be an advantage. Experience with an eQMS systems would be helpful too
  • Excellent communication skills and ability to work with people at all levels
  • Proactive, driven, pragmatic, open-minded, emotionally intelligent, positive and respectful approach to your work
This is a permanent position which is open to people with either more or less experience. You will be based on site in the new lab (which will either be in Limburg or Frankfurt - to be confirmed soon), with occasional opportunities to conduct some of your work from home. You may need to visit Beijing as part of your initial training.