Køge, Region Zealand, Denmark · On-site
QA Specialist – Magle BiopolymersExperienced, Pragmatic and Quality Focused About Magle Biopolymers Magle Biopolymers is part of the Magle Group – an international life science group with strong roots in dextran technolo…
Skills: GMP, ISO 13485, Batch Record Review, CAPA, Change Control
Køge, Region Zealand, Denmark · On-site
Maintenance Manager – Magle Biopolymers About Magle Biopolymers Magle Biopolymers is part of the Magle Group – an international life science group with strong roots in dextran technology. We develop and manufacture advan…
Skills: Maintenance Management, Preventive Maintenance, Troubleshooting, Supplier Management, Leadership
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The QA Specialist supports production and quality organizations by managing batch record reviews, deviations, and CAPAs. They are responsible for ensuring documentation accuracy and driving continuous improvement through LEAN initiatives.
Candidates must have 3+ years of QA experience in GMP or ISO 13485 environments and a degree in Life Science, Engineering, or Pharmacy. Proficiency in both Danish and English is required.
Magle Biopolymers is part of the Magle Group – an international life science group with strong roots in dextran technology. We develop and manufacture advanced polymer-based materials used in medical products, contributing to improving patients’ lives.
As a CDMO entity within the group, Magle Biopolymers operates in a regulated environment with high quality requirements. Quality, accountability, and cross-functional collaboration are core elements of our daily work, and we continuously strive to improve our processes and solutions.
We are looking for an experienced QA Specialist with a solid background in GMP and or ISO 13485. You enjoy working close to production, supporting daily operations and ensuring that quality decisions are made efficiently and based on sound judgement. You have a pragmatic mindset and thrive in a hands on QA role where your work contributes directly to reliable and safe production.
As QA Specialist, you will support the production and quality organisation with routine and operational QA responsibilities. You work independently with quality issues, manage documentation and ensure that processes and decisions follow established quality principles. Your work has a direct impact on product quality and delivery reliability.
As you will support our two sites, you will need to be present in both Køge and Hårlev.
Support production with QA responsibilities
Perform batch record review and support batch release activities in close collaboration with the QA team,
Handle deviations, CAPA, change controls and other day to day quality issues,
Participate in root cause investigations and help define effective corrective and preventive actions,
Ensure that documentation is clear, correct and completed according to internal procedures.
Work with continuous improvements
Identify opportunities to improve quality processes and routines within production,
Contribute to LEAN initiatives and other improvement activities where relevant,
Support implementation of revised procedures and new work practices.
Collaborate across functions
Work together with production, QC, supply chain and other departments,
Provide guidance on quality requirements and help colleagues apply risk based and pragmatic QA thinking,
Support internal audits and follow up on audit actions where needed.
Are an experienced QA professional
With 3+ years of QA experience from GMP or ISO 13485 environments,
Comfortable working independently with operational quality tasks.
Pragmatic and efficient
Able to identify what is critical and what is not,
Structured, quick in prioritisation and solution oriented.
Quality minded and collaborative
Skilled in communication and able to guide colleagues in quality matters,
A team player who works well with production and other departments.
Qualifications
Degree in Life Science, Engineering, Pharmacy or similar,
Strong understanding of quality principles and documentation practices,
Good command of Danish and English, spoken and written.
A role close to production where you can make a direct impact
A professional environment with committed colleagues
Opportunities for development and increased responsibility over time
At Magle Group, we work according to the IMPACT values:
Innovate – we continuously develop and improve
Motivate – we engage and support each other
Positive – we approach challenges constructively
Accountable – we take ownership of quality and results
Customer – we focus on customer and patient needs
Teamwork – we succeed through collaboration
We invite candidates for interviews on an ongoing basis and encourage you to submit your application as soon as possible.
For questions regarding the position, please contact QA Team Lead, Gitte Jacobsen at [email protected].
For HR-related questions, please contact HR Manager Rikke Tjustrup at [email protected].
Magle Group has a solid history within life science and has grown through strategic acquisitions. Today, the group consists of several specialized entities, including Magle Biopolymers, with a strong focus on dextran technology and CDMO services.
We bring innovations from idea to product.
We are a CDMO based in Malmö, Sweden, that serves companies in the pharmaceutical and medical device industry. We provide comprehensive services from development through manufacturing on a contract basis. Together with our partners, we take innovations from idea to product.
Offices: Agneslundsvägen 27, Malmö, Skane County 212 15, SE
We bring innovations from idea to product.
We are a CDMO based in Malmö, Sweden, that serves companies in the pharmaceutical and medical device industry. We provide comprehensive services from development through manufacturing on a contract basis. Together with our partners, we take innovations from idea to product.
Offices: Agneslundsvägen 27, Malmö, Skane County 212 15, SE
