Do you want to contribute to high quality and safety in our products?
We are now looking for a dedicated and meticulous employee with an interest in interpreting regulations within quality. With us, you will play an important role in ensuring that our products meet high standards and requirements.
The main tasks of the department are:
• Quality control in the form of reviewing manufacturing documentation,
• Handling deviations, complaints, and monitoring changes,
• Annual quality follow-up according to IVDR,
• Maintenance of our quality system,
• Internal audits from a quality perspective,
• Quality management of development projects,
• Risk analysis for products,
• Review of validations for equipment, software, and products.
The Position
Your main responsibilities will include:
• Reviewing manufacturing documentation to ensure that the documents are correctly and completely filled out.
• Issuing release certificates.
• Maintaining procedures owned by the QA department.
In the long term, we expect to start planning for additional IT support within the company. This will likely evolve into a task of participating in writing User Requirement Specifications with our expectations for the systems and participating in the validation of new systems.
Your Background and Qualifications:
• University degree in biochemistry, chemistry, biology, or equivalent.
• Good knowledge of software such as Microsoft products, primarily Word and Excel.
• Education and/or experience working under GMP/QSR or ISO13485.
• Excellent communication skills in Swedish and English, both spoken and written.
Preferred Experience:
• Experience in quality assurance within medical technology/pharmaceuticals.
• Experience working with quality review of manufacturing documentation under GMP for pharmaceuticals or medical technology.
• Interest and/or experience in software validation.
• Familiarity with MasterControl or TrackWise.
Who Are You?
We are looking for someone who, with great commitment, self-drive, high integrity, and attention to detail, approaches their work. We highly value strong collaboration skills, as effective teamwork is crucial for us to achieve our goals.
To thrive and succeed in this role, it is important that you have a positive attitude towards your surroundings. If you are also quality-conscious and structured with the ability to meet deadlines in an environment with many deadlines, can work independently and in a team, then you are the profile we are looking for.
Workplace and Culture
At Fujirebio, you will find a wonderful community where we work together in an engaging and dynamic environment to deliver products that meet customer expectations, regulatory requirements, and, not least, patient needs.
Employment
Start Date: February 1 or by agreement. The position is a permanent employment with a full-time commitment during daytime hours.
Want to Know More?
If you have questions about the position, please feel free to contact the recruiting manager Elin Ekström at
[email protected].
We welcome your application! Please submit your application by December 5.