QA / QC Specialist

2 weeks 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

    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 AGC Biologics Full time

    We are seeking a skilled Biopharmaceutical Manufacturing Specialist to join our team in Copenhagen.Job DescriptionThe successful candidate will be responsible for planning and performing cell culture steps in the manufacturing process, including preparation of media and feeds, performance of seed train, setup and use of single-use bioreactors, and daily...


  • Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full time

    At Novo Nordisk A/S, we are seeking a Senior IT QA Specialist to ensure the right quality level for future IT integrations between our organization and external warehouses. As a key member of our Supply Chain QA team, you will be responsible for ensuring Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) compliance at our external...


  • Copenhagen, Copenhagen, Denmark Chr. Hansen Holding AS Full time

    Job Description:We're seeking a talented Microbiologist to join our team as a QC Specialist. As a key member of our LAD team, you'll play a critical role in verifying and optimizing traditional microbial plating methods for probiotics and infant products. You'll work closely with other scientists and laboratory technicians to plan and implement efficient...


  • Copenhagen, Copenhagen, Denmark Aj Vaccines AS Full time

    Aj Vaccines A/S is seeking a Pharmaceutical QA Specialist to join our Quality Assurance department. In this role, you will have the opportunity to shape a brand-new position and significantly impact the Quality Assurance function.Key Responsibilities:Project Portfolio Management: Oversee and manage the QA project portfolio, ensuring alignment with strategic...


  • Copenhagen, Copenhagen, Denmark AGC Biologics Full time

    At AGC Biologics, we are dedicated to delivering the highest standard of service as we work side-by-side with our clients and partners.We currently have an exciting opportunity for a Senior Validation Specialist QC Chemistry to join our team in Copenhagen.This is a maternity cover position for 18 months where you will be driving PhI/II and PhIII/Commercial...


  • Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full time

    Are you a highly motivated, solution-oriented, and self-confident individual with a passion for working with Quality Assurance in a large organization? Can you transform requirements from the authorities into simple and compliant solutions that are understandable for our stakeholders globally? Do you have experience with supplier management or audits, and...


  • Copenhagen, Copenhagen, Denmark AGC Biologics Full time

    Job Description:We are seeking a Senior Quality Assurance Professional to join our QC General Analytics team in Copenhagen, Denmark. The successful candidate will be responsible for supporting the in-process stop/go testing 'outside normal working hours', i.e. evenings/nights, both on weekdays and weekends.Participate in analytical method...

  • R&D IT

    3 days ago


    Copenhagen, Copenhagen, Denmark Genmab AS Full time

    Our MissionAt Genmab, we believe in 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 Digital Product Owner, you will be part of our R&D IT & Digital team focusing on QC Lab Systems. You will lead the...


  • Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full time

    Are you a highly motivated, solution-oriented, and self-confident individual with a passion for working with Quality Assurance in a large organization? Can you transform requirements from the authorities into simple and compliant solutions that are understandable for our stakeholders globally?Do you have experience with supplier management or audits, and are...


  • Copenhagen, Copenhagen, Denmark Ascendis Pharma AS Full time

    **About Us**At Ascendis Pharma A/S, we're driven by our passion to transform the lives of patients through innovative therapies. Guided by our core principles of patients, science, and passion, we leverage our TransCon technology platform to pioneer new treatments addressing critical medical needs. Our pipeline consists of several cutting-edge therapies...


  • 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 industryAs a QA/CV Sourcing Specialist, your...


  • Copenhagen, Copenhagen, Denmark AGC Biologics Full time

    At AGC Biologics, we are committed to bringing hope to life by enabling life-changing therapies for patients worldwide. As a Senior Validation Specialist in our QC Chemistry team, you will play a crucial role in driving PhI/II and PhIII/Commercial method validation activities.Responsibilities:Drive PhI/II and PhIII/Commercial method validation...


  • Copenhagen, Copenhagen, Denmark AGC Biologics Full time

    The QC Chemistry Department is responsible for supporting the production of new or marketed biopharmaceuticals by performing analytical testing and validating various analytical procedures according to ICH guidelines from clinical phase I to phase III and commercial. Our team works closely with cross-functional departments and external partners to ensure...


  • Copenhagen, Copenhagen, Denmark Ascendis Pharma AS Full time

    Passionate about Quality Assurance with expertise within outsourced GMP activities and development projects? Ascendis Pharma invites you to explore the role of our newest QA Specialist / QA Professional for Development GMP activities. With roots spanning Denmark, Germany, and the United States, Ascendis Pharma A/S emerges as an innovative and dynamic...


  • Copenhagen, Copenhagen, Denmark AGC Biologics Full time

    AGC Biologics is 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.Our mission is to work together with our customers to improve patients' lives by bringing new biopharmaceuticals to...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About UsAt Genmab, we're dedicated to transforming the lives of patients through innovative and differentiated antibody therapeutics. We believe in the importance of teamwork, innovation, and expertise in driving success.About the RoleWe're seeking a highly skilled GMP QA Manager to join our team, responsible for quality oversight of starting materials,...

  • QA Koordinator

    2 weeks ago


    Copenhagen, Copenhagen, Denmark AJ Vaccines Full time

    Vi søger en QA Senior Specialist til at fremme kvaliteten af vores produkter ved hjælp af din gode erfaring fra QA-stillinger.**Som QA Senior Specialist vil du:indsætte strategier for bedre livskvalitet som synergi oven på eksisterende feedbackSamvirke så langt muligt uden direkte henvisningindføre effektiv kontrolplan for hver objektet per sit...


  • Copenhagen, Copenhagen, Denmark Ascendis Pharma AS Full time

    Passionate about Quality Assurance with expertise within outsourced GMP activities and development projects?Ascendis Pharma invites you to explore the role of our newest QA Specialist / QA Professional for Development GMP activities.With roots spanning Denmark, Germany, and the United States, Ascendis Pharma A/S emerges as an innovative and dynamic...