Quality Specialist for broad quality work in Utilities
Remote
- Location
- Remote
- Company
- Statens Serum Institut
- Working hours
- Full-time
- Posted
- 30 September 2026
- Application deadline
- 18 October 2026
- Category
- Quality engineer
About the job
Quality Section
You shall support the Supply's work to ensure robust and compliant handling, storage and distribution of medicines and vaccines.
As part of the Supply's Quality Section you will work broadly with quality assurance and contribute to ensuring that processes, equipment, facilities and documentation comply with applicable GxP requirements and internal procedures.
Your everyday life with us
You will participate in the daily operation and development of the Supply's quality area and work independently and in collaboration with colleagues and other disciplines.
Your tasks will include
- Handling, investigation and follow-up on deviations and contribute to root cause analyses and corrective and preventive actions (CAPA).
- Preparation, coordination and follow-up on change requests.
- Development and maintenance of procedures, instructions and other GxP documentation.
- Preparation and participation in risk and consequence analyses.
- Periodic evaluations of equipment, systems and processes.
- Follow-up on quality activities, observations, actions and deadlines.
- Participation in self-inspections, audits and regulatory inspections and follow-up on observations.
- Training and professional sparring with employees in the Supply.
- Contributing to ongoing improvement and development of quality processes and workflows.
- Participation in cross-cutting projects and implementation of changes with impact on the Supply's quality area.
As part of the position you will obtain a special area of responsibility within qualification and contribute to ensuring that relevant equipment and facilities are documented as suitable for the intended use and maintained in a qualified state.
The tasks will include
- Planning and coordination of qualification and re-qualification activities.
- Preparation and review of requirements specifications, risk assessments, qualification protocols, test plans and reports.
- Participation in execution and documentation of relevant IQ-, OQ- and PQ-activities.
- Assessment of test results, acceptance criteria and any deviations.
- Follow-up on equipment qualified status and need for re-qualification.
- Collaboration with relevant internal domains, QA and external suppliers regarding qualification activities.
The area of responsibility may include cooling and freezing facilities, temperature monitoring, alarm systems, transport equipment and temperature-controlled transport solutions.
Your education, experience and personal qualifications
We are looking for someone who is curious about quality and motivated to work with quality assurance in a complex supply organization. You may be a recent graduate or have a few years' experience from a quality-related function. The most important is that you want to work broadly with quality and develop your competencies within GxP, quality systems and qualification.
We imagine that you
- Have a relevant natural science, pharmaceutical, technical, health science or equivalent education.
- Have an interest in quality assurance and regulatory requirements.
- Work in a structured, systematic and quality-conscious manner.
- Have an eye for detail without losing sight of the overall process.
- Are analytical and can grasp complex problems.
- Have an interest in both documentation, processes and equipment.
- Can work independently, take responsibility for own tasks and see them through to completion.
- Thrive in cross-disciplinary collaboration and can communicate clearly and constructively.
- Can communicate in writing and verbally in Danish and English.
Experience with GDP/GMP, quality systems, deviations, CAPA, change control, qualification or validation is an advantage but not a requirement. The most important is your professional curiosity, your structured approach and your willingness to learn.
We offer
Your skills and commitment contribute to solving our shared core task.
SSI is a workplace internationally recognised for solving national and global health tasks. You will become part of an organization with 900 employees that carries out meaningful tasks that strengthen human and animal health through research and preparedness.
Our daily life is characterised by many diverse tasks, open doors and broad collaboration with engaged and skilled colleagues. You will have the possibility of a flexible everyday life with a good balance between work and leisure, as SSI is a workplace with a 37-hour workweek including lunch break, flexitime arrangement and the possibility for home office and flexible working hours.
At SSI we have an active staff and sports association (IK-SERA) with group training and exercise facilities, Friday bar and various social events – and our campus even has tennis courts and its own child care facility. SSI is centrally located in Copenhagen with green areas and good public transport options (bus and metro) and free parking on site.
Does the job sound like something for you?
Send us your CV and application. We kindly ask you not to include a photo in your CV, as we strive for a more inclusive recruitment process with equal opportunities for all our job applicants.
We expect to conduct interviews from week 43.
If you have further questions about the position or the application process you can contact section leader Anne Lykkegaard Widlund, [email protected]. You can read more about how to apply and the recruitment process on Job at SSI
Your terms of employment
You will be employed under the current agreement between Akademikernes Centralorganisation and the Ministry of Finance (AC agreement). Depending on qualifications and experience, you may be placed as an academic employee or a senior consultant.
We look forward to hearing from you.
Application deadline: Oct 18, 2026
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Quality Specialist for broad quality work in Utilities
Statens Serum Institut · Remote