Are you an experienced QA Specialist with a passion for quality? Do you love working cross-functionally with colleagues to develop processes and find better, more efficient ways to work? Are you dedicated to make an IMPACT in the life of others? Sound like you? Then you should consider joining us at Magle Biopolymers!

As a QA Specialist at Magle Biopolymers, you will play an important role in the business, enabling us to bring life-changing healthcare innovations to patients. Magle Biopolymers produces APIs, Medical Devices and technical-grade pharmaceutical materials, supporting customers worldwide. You will be assigned to different projects to represent the quality team, ensuring that our high-quality products are key to our success.

To succeed in the role of QA Specialist at Magle Biopolymers, you should enjoy working both independently and with others. Strong collaboration and communication skills are crucial for this position. You should also feel comfortable in a changing environment and be able to adjust your work depending on business needs. We are looking for someone who is organized, driven, efficient, and capable of explaining and supporting the organization in quality matters.

Key Responsibilities:

• Able to work multisite (one quality system for Koge and Hårlev sites, apart ca 15 km from each other)
• Review batch documentation (in close collaboration with production environment, hence experience in Biopolymers is highly advantageous).
• Provide flexible and collaborative support to Deviations, Change Control and CAPA processes.
• QA writing, review and approval of Standard Operating Procedures (SOPs).
• Participate in improvements and qualification / validation processes (experience on this is highly advantageous).
• Manage changes, deviations, and complaints.
• Provide customer support and participate with the team in both customer and authority audits.
• Provide support within the team for qualification and evaluation of suppliers.
• Participate in customer and regulatory inspections, investigations, and risk assessments.
• QA encompasses a broad range of tasks, offering opportunities for development in various areas.

To succeed in this position:

• Experience from Quality work for 5 years or more.
• University degree in chemistry, pharmaceuticals, or an equivalent engineering discipline.
• Previous work experience in pharmaceutical or Medical Device operations according to GMP part II and ISO 13485.
• Able to handle "learning by doing" and willing to act even if there is a risk of mistakes (get it done attitude).
• Lead by example, be a partner to production peers, be humble and open to learn and teach by doing.
• You must be able to work independently and to speak up when changes need to be addressed.
• Excellent proficiency in both Danish and English, spoken and written, as both languages are used in the job.
• Experienced user of Microsoft Office and electronic/paper Quality Management systems.
• Experience in QA work for projects in clinical phases is highly advantageous.

We are a value driven organisation and you need to share our ambition to work to make an IMPACT for patients. We know we can make a difference by setting our mind to being Innovative - Motivated - Positive - Accountable- Customer focused and work as a Team. If you believe you share our values and the above position fits your experience, we would love to hear from you.

Please send in your application if this sounds like a position for you, but no later than Jan.31^st 2025. Please submit your CV and a short cover letter. The position is based at our offices in Koge and Hårlev and is a full-time position.

To find out more about us, please visit our group webpage at www.maglegroup.com.