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 Gitte.jacobsen@maglegroup.com
For HR-related questions, please contact HR Manager Rikke Tjustrup at rikke.tjustrup@maglegroup.com
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.
The Magle Group aims to establish itself as a leader in high-quality life-changing healthcare innovations to meet medical needs through scientific excellence. Through innovation and meeting medical needs, we will expand our proprietary technology to improve patients’ quality of life and treatment outcomes. Our winning aspiration is driven by generating clinically reliable data to build value in our technology and move quickly to market. Our Group includes two operative companies with excellent success records operating under the Magle Group banner. Magle Chemoswed AB is a contract development and manufacturing organization (CDMO) that has rapidly built a strong reputation for its expertise, innovation, and high-quality development and manufacturing expertise. Magle PharmaCept GmbH is dedicated to bringing our degradable starch microsphere products to the market through our sales and marketing force.
