QA Specialist, Experienced, Pragmatic and Quality Focused

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? 

Does this sound like you? Then you should consider joining us at Magle!

About the Role

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.

You will,

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.

You are,

An experienced QA professional

• With 3 to 5 or more 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 solutions 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.

We offer

• 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

• Attractive employment conditions

Besides competence 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.

Interested?

Send your application and CV as soon as possible, but no later than 27/2. We review applications on an ongoing basis and hire when we have found the right candidate.

If you have any questions regarding the role and QA, please reach out to our Group Director of QA and RA Jenny Ekberg; jenny.ekberg@maglegroup.com

If you have any HR related questions, please reach out to our Payroll Manager Kristine Garcia Castillo Samonte; kristine.garcia@maglegroup.com