Experienced QA Specialist Quality Assurance

6 days ago

Køge, Denmark Magle Chemoswed Full time

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 making 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 organization 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. 31st 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 .

#J-18808-Ljbffr

  • Quality Assurance Specialist for Mechanical, Electrical and Plumbing Systems

    2 weeks ago

    Køge, Køge Kommune, Denmark Itinera Denmark Full time

    About the RoleWe are seeking a skilled Quality Assurance Specialist to join our dynamic team at Itinera Denmark. As a QA Specialist, you will play a crucial role in ensuring that all Mechanical, Electrical and Plumbing (MEP) systems on our construction projects meet the required standards and specifications.Key ResponsibilitiesInspection and Monitoring of...

  • Highly Skilled Quality Assurance Professional

    6 days ago

    Køge, Køge Kommune, Denmark Magle Chemoswed Full time

    We are Magle Biopolymers, a leading producer of APIs, Medical Devices, and technical-grade pharmaceutical materials. Our goal is to bring life-changing healthcare innovations to patients worldwide.As a QA Specialist at Magle Biopolymers, you will play a crucial role in ensuring the quality of our products. You will be assigned to different projects to...

  • Quality Assurance Inspector for Construction Projects

    2 weeks ago

    Køge, Køge Kommune, Denmark Itinera Denmark Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Inspector to join our dynamic team at Itinera Denmark. As a QA Inspector, you will play a crucial role in ensuring that construction activities meet specified quality standards, codes, and regulations.Key ResponsibilitiesInspection and MonitoringInspect construction activities: Monitor on-site...

  • QA Civil Inspector

    1 week ago

    Køge, Denmark Itinera Denmark Full time

    QA Civil Inspector Are you looking for a career with growth and limitless opportunities? Do you want a role where your superpowers can be leveraged to the maximum? The scale and ambition of our construction business means you can really find your element with us. We provide all the learning and development you need to expand your horizons. About the Role: ...

  • QA MEP Inspector

    1 week ago

    Køge, Denmark Itinera Denmark Full time

    QA MEP Inspector Are you looking for a career with growth and limitless opportunities? Do you want a role where your superpowers can be leveraged to the maximum? The scale and ambition of our construction business means you can really find your element with us. We provide all the learning and development you need to expand your horizons. About the Role: We...

  • Production Manager

    1 week ago

    Køge, Denmark Magle Chemoswed Full time

    Position Overview We are seeking an experienced and highly skilled GMP and ISO 13485 Production Manager to lead and optimize our production operations in a regulated environment. This role requires a strategic leader with expertise in GMP and ISO 13485 standards, a strong commitment to "right-first-time" principles, and proficiency in Swedish, Danish, and...

  • Warehouse Compliance Specialist

    1 week ago

    Køge, Køge Kommune, Denmark Novo Nordisk AS Full time

    We are seeking a highly skilled Warehouse Compliance Specialist to join our team at Novo Nordisk Pharmatech (NNPR). This role will play a crucial part in ensuring compliance with Good Manufacturing Practice (GMP) regulations, optimizing warehouse processes, and contributing to the company's growth.About the RoleAs our new Warehouse Compliance Specialist, you...

  • Senior Project Manager for Pharmaceutical Manufacturing

    1 month ago

    Køge, Køge Kommune, Denmark Novo Nordisk AS Full time

    At Novo Nordisk Pharmatech A/S, we are seeking an experienced Senior Project Manager to join our Project Management Office (PMO) in Køge. The successful candidate will be responsible for leading medium to large-scale projects across various aspects of pharmaceutical manufacturing.About the RoleThis is a challenging and rewarding opportunity for a skilled...

  • Leaders to Associate Manager Pipeline

    4 months ago

    Køge, Denmark Novo Nordisk AS Full time

    Jobbeskrivelse Placering Køge, Denmark Jobkategori Manufacturing Are you ready to take the next step and pursue a life-changing career at Novo Nordisk? We have opportunities at all levels making it possible to challenge you and put your skills into play. Joining the Associate Manager Pipeline By applying for the pipeline, you will be considered as a...

  • Occupational Health and Safety Specialist

    2 weeks ago

    Køge, Køge Kommune, Denmark Itinera Denmark Full time

    About the Role:We are seeking an Occupational Health and Safety Specialist to join our dynamic team at the Køge Hospital Project. You will be part of a growing team with colleagues from various nationalities, where our positive approach to diversity is reflected.The successful candidate will support in overseeing site OHS supervision and ensuring compliance...

  • Leaders to Associate Manager Pipeline

    7 days ago

    Køge, Denmark Novo Nordisk AS Full time

    Are you ready to take the next step and pursue a life-changing career at Novo Nordisk? Maybe you have a strong leadership background, or you might be at the start of your leadership career – we have opportunities at all levels making it possible to challenge you and put your skills into play. Joining the Associate Manager Pipeline By applying for the...

  • Warehouse GMP Professional

    7 days ago

    Køge, Denmark Novo Nordisk AS Full time

    Are you ready to make a significant impact on maintaining warehouse processes? Do you possess a strong dedication to ensuring compliance with Good Manufacturing Practice (GMP) regulations? If so, an exciting opportunity awaits you to become a valued member of our Warehouse team at Novo Nordisk Pharmatech (NNPR). The Position As our new Warehouse GMP...

  • Ambitious Associate Manager Seeking New Challenges

    4 weeks ago

    Køge, Køge Kommune, Denmark Novo Nordisk AS Full time

    Job OverviewWe are seeking an ambitious and experienced Associate Manager to join our team at Novo Nordisk A/S. As a key player in our organization, you will be responsible for leading and managing teams across various areas, including Production, Quality, and IT.SalaryThe estimated salary for this position is between €60,000 - €80,000 per year,...

  • Senior Occupational Health and Safety Professional

    2 months ago

    Køge, Køge Kommune, Denmark Itinera Denmark Full time

    Transform Healthcare Delivery with UsWe are seeking an experienced Senior Occupational Health and Safety (OHS) professional to join our dynamic team at the Køge Hospital Project. This is an exciting opportunity for a motivated individual who wants to make a difference in shaping the future of healthcare delivery.About the Role:The Senior OHS professional...

  • Strategic Associate Manager Role for Operational Excellence

    2 weeks ago

    Køge, Køge Kommune, Denmark Novo Nordisk AS Full time

    About UsNovo Nordisk A/S, a global leader in the pharmaceutical industry, is seeking an experienced and ambitious individual to join our team as a Strategic Associate Manager. This role presents an exceptional opportunity to drive operational excellence across various teams within our organization.Job SummaryWe are committed to delivering high-quality...

  • Project Lead for Pharmaceutical Ingredients

    4 weeks ago

    Køge, Køge Kommune, Denmark Novo Nordisk AS Full time

    Job OverviewAt Novo Nordisk Pharmatech A/S, we are seeking an experienced Project Lead for Pharmaceutical Ingredients to join our Project Management Office (PMO) in Køge, Denmark.About the RoleThis is a challenging opportunity to lead medium to large projects within our manufacturing and laboratory facilities. You will be responsible for creating project...

  • Automation Project Manager for Large-Scale Production

    3 weeks ago

    Køge, Køge Kommune, Denmark Novo Nordisk AS Full time

    Job OverviewWe are seeking an experienced Automation Project Manager to join our team in Köge, Denmark.About the JobThis is a unique opportunity to lead large-scale projects in production automation, working closely with cross-functional teams and stakeholders. As a seasoned project manager, you will be responsible for developing and executing project...

  • Project Manager for Investment Projects

    7 days ago

    Køge, Denmark Novo Nordisk AS Full time

    Jobbeskrivelse Placering Køge, Denmark Jobkategori Project Management & Agile Experience the thrill of driving change as a Project Manager at Novo Nordisk Pharmatech. Use your experience to take charge of cross-organisational projects with medium and high complexity. You will be positively challenged by the variety of our projects and their purpose, but...

  • Automation Expert Project Lead

    6 days ago

    Køge, Køge Kommune, Denmark Novo Nordisk AS Full time

    Are you a seasoned Automation expert with a passion for leading projects? Do you want to leverage your expertise in Automation and Project Management to drive innovation at Novo Nordisk Pharmatech?About the RoleWe are seeking an experienced Automation Expert to join our team as a Project Lead. As a key member of our Project Management Office (PMO), you will...

  • Senior Construction Contract Manager

    2 weeks ago

    Køge, Køge Kommune, Denmark Itinera Denmark Full time

    About the Role: We are seeking an experienced Senior Construction Contract Manager to join our dynamic and diverse team at Itinera Denmark. This is a unique opportunity to take on a challenging role where you will be responsible for overseeing the management, drafting, review, and administration of contracts between clients, contractors, and...