Quality Assurance Specialist 

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You want…  

a crucial position where you will be responsible for supporting the maintenance and continuous improvement of a Quality Management System (QMS). You want to use your experience in working with validation, GAMP, Annex 11, and are highly motivated to create safe and effective adjuvants for use in vaccines and want to be part of a world-leading organization.  


You will…  

primarily support the development implementation, and maintenance of validation strategies and plans for manufacturing processes, equipment, and systems. Furthermore, you work closely with the QA leadership team to develop and implement validation plans, including the execution of validation protocols, data analysis, and report writing. In addition, you will assist in the implementation and maintenance of GAMP (Good Automated Manufacturing Practice) guidelines, ensuring that computerized systems comply with industry standards and regulations. Supporting the implementation and maintenance of Annex 11 requirements for electronic records and signatures will also be part of your responsibilities. You will participate in deviation, Corrective and Preventive Action (CAPA), and change control handling as well as provide support in conducting internal audits and participating in inspections from authorities and audits from customers. Additionally, you will collaborate with cross-functional teams to identify and drive improvements in our QMS and related processes as well as provide general support to the QA department, including documentation review and approval, training, and other quality-related tasks.  


You’ll join…  

a passionate quality department that works together to set a high standard for collaboration across the organization. You will join a collaborative and supportive environment that allows you to grow. The team is dedicated to keeping the world safe and is passionate about driving change. You will be part of a world-leading adjuvant specialist organization that operates across 37 countries. 


You have… 

  • A Bachelor’s or Master’s degree in Chemistry, Biology, Pharmacy, or a related field. 
  • At least 3 years of experience in a Quality Assurance role in the pharmaceutical industry, with experience in validation, GAMP, Annex 11, and other quality-related tasks. 
  • Strong knowledge of pharmaceutical aseptic manufacturing processes, regulations, and guidelines. 
  • Experience in deviation handling, CAPA, and change control. 
  • Excellent attention to detail and ability to work in a fast-paced environment. 
  • Experience with inspections and audits from regulatory authorities and customers. 
  • Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams. 


If you want to hear more about this opportunity and the company, or if you have any questions regarding the position, please do not hesitate to contact us. If you wish to apply for the position, please send an updated version of your CV, together with what questions you might have, and we will get in touch with you soon.

2021_10_27_BSE_Medarbejderportrætter_1510 (Anpassat)



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