QA / QC Specialist

3 days ago


Copenhagen, Copenhagen, Denmark Eupry Full time

Eupry Copenhagen, Capital Region of Denmark, Denmark

Eupry is a leader in temperature monitoring solutions for GxP industries, ensuring compliance with Good Distribution Practice (GDP), Good Manufacturing Practice (GMP), and Good Laboratory Practice (GLP) requirements. We are seeking a dedicated and detail-oriented QA / QC Specialist to join our team and support our mission of delivering high-quality, compliant solutions.

Key Responsibilities:

  • Maintain and continuously improve our Quality Management System (QMS) to ensure compliance with ISO 9001, ISO 17025, ISO 27001, and ISO 14001, as well as GxP regulations
  • Respond to internal and external quality-related questions and questionnaires, ensuring alignment with regulatory expectations
  • Validate internal and external products and systems to meet GxP requirements, primarily following GAMP5 guidelines, ensuring data integrity and compliance in all processes
  • Manage and handle Corrective and Preventive Actions (CAPAs) across the company to enhance efficiency and compliance in operations
  • Plan, execute, and document internal audits to maintain regulatory adherence and support continuous improvement
  • Author, review, and update internal Standard Operating Procedures (SOPs) and quality documentation to ensure compliance with industry requirements
Requirements:
  • A background in Quality Assurance, Quality Control, or a related field (Engineering, Life Sciences, or similar preferred)
  • Experience working with Quality Management Systems and regulatory compliance in GxP environments is preferred
  • Knowledge of any ISO standards (ISO 9001, ISO 17025, ISO 27001, ISO 14001) and GxP regulations, especially GAMP5 is preferred
  • Analytical mindset with the ability to assess processes, identify gaps, and implement improvements to meet compliance standards
  • Excellent communication skills, both written and verbal, to effectively engage with internal teams and external customers
  • Experience in CAPA management, risk assessment, and internal auditing is a plus
  • Detail-oriented, proactive, and capable of working independently as well as collaboratively within a compliance-driven environment
Benefits:
  • A dynamic and collaborative work environment in a company dedicated to compliance and innovation in GxP industries
  • Opportunities for professional development, training, and continuous learning in regulated environments
  • The chance to contribute to high-quality standards in an organization that prioritizes compliance, quality, and customer trust
  • A friendly workplace with a growth mindset
  • Opportunity for getting a lot of responsibility within your field.

If you are passionate about quality and regulatory compliance and want to be part of a company that is in rapid growth, we would love to hear from you

Seniority level

Associate

Employment type

Full-time

Job function

Quality Assurance

Industries

IT Services and IT Consulting

#J-18808-Ljbffr

  • Copenhagen, Copenhagen, Denmark AJ Vaccines Full time

    Vi redder menneskeliv på verdensplan; Vil du være med? Hvis du brænder for at gøre en forskel og sikre kvaliteten af livsvigtige produkter, så er denne stilling måske noget for dig. Vi søger lige nu flere medarbejdere til vores afdeling. Som QA Senior Specialist i QA-afdelingen spiller du en afgørende rolle i vores mission og får mulighed for at...


  • Copenhagen, Copenhagen, Denmark AJ Vaccines Full time

    KvalitetsledelsenI rollen som QA Senior Specialist er du ansvarlig for QC supporterer og godkendelse af GMP-dokumentation, afvigelser, CAPA og ændringssager for QC. Derudover er du ansvarlig for QA faciliter og udstyr, samt IT-godkendelse af analyse- og testudstyr.TilmeldesprocedurenDu bliver en del af et team, der er fast bestemt på at sikre kvaliteten af...


  • Copenhagen, Copenhagen, Denmark AJ Vaccines Full time

    MissionenVi søger QA Senior Specialist til vores afdeling, der har hovedansvaret for (i) QC, (ii) faciliteter og udstyr og (iii) IT. I rollen som QA Senior Specialist er du ansvarlig for QC supporterer og godkendelse af GMP-dokumentation, afvigelser, CAPA og ændringssager for QC.TilmeldingenDu får mulighed for at arbejde med åben innovation og opdagelse...


  • Copenhagen, Copenhagen, Denmark AJ Vaccines Full time

    Om osAJ Vaccines er en international virksomhed, der arbejder med at sikre kvaliteten af livsvigtige produkter. Vi søger nu flere QA Senior Specialist til vores afdeling.JobbetI rollen som QA Senior Specialist spiller du en afgørende rolle i vores mission om at redde menneskeliv på verdensplan. Du vil være ansvarlig for QC supporterer og godkendelse af...


  • Copenhagen, Copenhagen, Denmark emagine Consulting AS Full time

    Join our team as a QA/CV Sourcing Specialist in Copenhagen, Denmark Are you ready to drive impactful changes for some of the top-tier IT freelancers in Denmark and across Europe? Come aboard our dynamic Sourcing Back Office team and step into the role of a QA/CV Sourcing Specialist in the rapidly expanding IT industry As a QA/CV Sourcing Specialist, your...


  • Copenhagen, Copenhagen, Denmark Teton Aps Full time

    Quality Assurance Full-time Copenhagen, DK Teton is building AI technology that empowers nurses and frontline care staff to deliver more effective care with less stress. Our solution helps hospitals and care homes maintain critical care standards and patient safety, addressing the global nursing shortage with innovative AI tools. At Teton, we operate...

  • QA Academic, CMC

    1 day ago


    Copenhagen, Copenhagen, Denmark Lundbeck AS, H Full time

    Would you like to contribute to the development of new treatments for brain diseases by ensuring patient safety and GMP compliant Investigational Medicinal Product (IMP) to clinical trials? Then this is a great opportunity to join our team collaborating with multiple stakeholders while leveraging your professional and personal skills. We offer an exciting...


  • Copenhagen, Copenhagen, Denmark Trustpilot AS Full time

    About the JobWe're looking for a highly skilled Salesforce QA specialist to join our team. As a key member of our creative team, you will be responsible for conducting end-to-end testing of Salesforce software, Zuora, and payment gateways to ensure seamless integration and functionality across our systems.Main Responsibilities:Test Salesforce software,...


  • Copenhagen, Copenhagen, Denmark AJ Vaccines Full time

    Vi søger en erfaren QA-specialist til at støtte vores arbejde med at sikre høj kvalitet af livsvigtige produkter.Jobbet omhandler:Godkendelse af GMP-dokumentation, inkl. URS/IQ/OQ/PQ og risikovurderingerStyret af QA-faciliteter og udstyr i samarbejde med QA-teametSamtlig else: QA-support, spørgsmål efter dato Hvem er vi?AJ Vaccines er en virksomhed som...

  • Manager, QA GMP

    3 days ago


    Copenhagen, Copenhagen, Denmark Genmab Full time

    At Genmab, we're committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being...


  • Copenhagen, Copenhagen, Denmark AGC Biologics Full time

    About the RoleWe are a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in multiple...


  • Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full time

    Are you ready for a role as Analytical Specialist within analytical methods used for testing of peptide/protein-based injectable drug products in Novo Nordisk? Are you eager to use your solid experience and competencies within analytical testing techniques such as HPLC, UHPLC, AAS, Raman, ICP and Container Closure Integrity testing to guide and support your...


  • Copenhagen, Copenhagen, Denmark The HubDanske Bank Full time

    Do you have a flair for product quality? And are you curious to see if you can put your QA/RA experience to work and place our products in new markets? Maybe you have been working with product registrations for a while and now you would like to work more holistically with every part of a QMS system. Maybe you are a seasoned QA specialist that would like to...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    Genmab is an innovative biotech company dedicated to transforming the lives of people with cancer and other serious diseases through cutting-edge antibody medicines.About the RoleThis GMP QA Manager position offers a unique opportunity to contribute to the development and delivery of novel antibody therapies to patients.Key ResponsibilitiesEnsuring the...


  • Copenhagen, Copenhagen, Denmark PRS Full time

    PRS Copenhagen Municipality, Capital Region of Denmark, Denmark Quality Engineering Manager About the Company - Opportunity for the Quality Manager to join the Data Centre Team. The Quality Manager is the primary point of contact for their project or building on the campus and responsible for managing the daily QA/QC activities at the building level and...


  • Copenhagen, Copenhagen, Denmark AGC Biologics Full time

    Are you passionate about ensuring the quality and integrity of biopharmaceutical products? Do you have a strong background in analytical method development and validation?We are looking for a highly skilled Senior Bioassay Specialist to join our QC General Analytics team at AGC Biologics. In this role, you will be responsible for developing and implementing...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    As a Senior Associate CMC for the Stability Team, you will play a crucial role in ensuring the stability of our products during clinical development and commercialization. Your expertise will help us maintain compliance with regulatory requirements and ensure the quality of our products.In this role, you will collaborate with the CMC Project Manager, QA, and...


  • Copenhagen, Copenhagen, Denmark Ferrosan Medical Devices AS Full time

    Do you want to be a part of our Quality Control team in a successful company with a unique impact on global healthcare? Grab this opportunity to join a rapidly growing company, ready to invest in you. Here you will not only get to impact the production and development of our products; you will also have every opportunity to develop and grow your own...


  • Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full time

    We are looking for a talented Scientific Method Specialist to join our team at Novo Nordisk A/S. In this role, you will be responsible for supporting chemical analysis of injectable drug products, both internally in the department and globally in QC laboratories and Contract Manufacturing Organisations (CMOs).You will ensure that our analytical methods are...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    Transforming Lives through Innovative Cancer TreatmentAbout the RoleGenmab is committed to building extraordinary futures together by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. As a Senior Associate CMC for the Stability Team, you will be an integral part of...