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- Quality Assurer at APL in Strängnäs
Quality Assurer at APL in Strängnäs
Apotek Produktion & Laboratorier ABSödermanlands län, Strängnäs
Previous experience is desired
16 days left
to apply for the job
APL, Apotek Produktion & Laboratorier AB, is tasked with manufacturing extemporaneous medicines which are individualized medications for a specific patient, aimed at improving and saving lives. Many formulations are made for children and adults with various types of hypersensitivity. APL is state-owned and one of Europe's largest manufacturers of extemporaneous medicines and is also an established contract manufacturer within the Life Science industry with resources for development, manufacturing, and analysis of pharmaceuticals. APL's approximately 600 employees work at five manufacturing units in Stockholm, Gothenburg, Malmö, Umeå, and Strängnäs.
For more information, please visit www.apl.se
APL's Strängnäs facility specializes in the production of penicillins in various formulations such as tablets, mixtures, capsules, and dose bags. Here in Strängnäs, we currently have about 80 people and are in an expansion phase with new projects and interesting products. The work environment is characterized by good camaraderie, high competence levels, and short decision-making paths.
About the role:
As a quality assurer, you will play a central role in our quality work. The job involves a lot of contacts and collaboration with other functions within the company, such as production, process technology, the laboratory, Supply Chain, as well as external contacts with our customers and suppliers.
Responsibilities:
· Ensure that the operations comply with GMP and other regulatory requirements
· Review and approve documents related to QC such as analytical methods and validation documentation regarding methods and instruments
· Issue and approve master data and register and approve projects in the LIMS system
· Continuously support and follow up on customer requests for regulatory support and guide the site in regulatory issues, e.g., before changes in operations.
· Review and approve manufacturing documentation
· Assess that raw materials, packaging, and contract-manufactured products meet applicable quality requirements
· Write and approve quality management documents
· Handle deviations, CAPA, and change requests
· Participate in projects and conduct internal and external audits
· Validate processes, equipment, and IT systems
· Train staff in quality and GMP
· Contribute to continuous improvement efforts within the quality system
Qualifications:
· Scientific university degree (pharmacy, chemistry, biotechnology, or equivalent)
· At least 3 years of experience in quality work within the pharmaceutical industry where GMP has been applied
· Good knowledge of GMP, GDP, and regulatory requirements (e.g., EMA, FDA)
· Experience in working with regulatory issues
· Experience in supplier qualification is an advantage
· Strong communication skills in Swedish and English
· As a person, you thrive in a fast-paced work environment, are flexible, solution-oriented, and meticulous. You enjoy varied tasks, are proactive and self-driven, and can reprioritize your work when needed. You are unpretentious and analytical and have the ability to see the big picture.
We offer:
· A meaningful job that impacts people's health
· An engaged team and opportunities for professional development
· Competitive terms and flexibility
· A work environment that encourages improvement and innovation
· Secure and favorable employment conditions including collective agreements, reduced working hours, and wellness benefits.
· A job in an expanding company with exciting new products that contribute to health and well-being in society.
· The position is a permanent employment located in Strängnäs.
With us, you will find APL is characterized by an open and dynamic atmosphere with short decision-making paths. For you to thrive, our values of being businesslike, responsive, solution-oriented, and responsible must resonate with you.
All employees have an individual development plan and clear goals that are continuously followed up. This gives everyone the opportunity to influence their own situation and contribute to our collective development, and we actively encourage internal mobility.
You will have access to our benefits and offerings, such as wellness grants and subsidized lunches at two of our nearby restaurants. At the workplace, there is the possibility of massage and various forms of recreational activities. We have collective agreements with IF Metall (Blue Collar) and with Unionen, Sveriges Ingenjörer, Naturvetarna, and Ledarna (White Collar) and associated benefits, such as occupational pension, insurance, flexible hours, reduced working hours, and compensation for public holidays.
To the extent that the position allows, there is an opportunity for partial remote work.
Application The application deadline is March 13, 2026. Applications are made via the link in the advertisement; we do not accept applications via e-mail. We work with a continuous selection process, and the position may be filled before the application deadline.
For information If you have questions about the position, please feel free to contact nn via email: [email protected] or phone: 073-962 8083
Other Before any employment, you will undergo an alcohol/drug test, and we will conduct a background check on you via Bakgrundskollen.se.
Welcome to share an exciting future with us at APL!
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