QA Specialist

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Holbæk

QA Specialist


[xxxxx] is seeking an experienced, competent new colleague to join our International QA team in a dynamic and growing company. We are 15 employees in QA, responsible for ensuring GMP and GDP compliance and oversight in relation to development, contract manufacturing and distribution of APIs and drug products. We have close cooperation with many different parties - internally and externally - which provides a variety in the daily tasks.

The international QA team
As QA Specialist in the International QA team, you will be part of our highly dedicated team consisting of 4 International QA Directors working with a broad and challenging range of QA tasks related to our external contacts such as quality oversight of suppliers, contract manufacturing organizations, [xxxxx] affiliates, partners and customers, master batch documents review, processing of quality agreements, evaluation of deviations and change requests from external parties, participation in technical transfer projects and as well as validation and ad hoc projects. Participation in auditing is expected, which includes a few days of travelling per year.
The QA Specialist role is a new role in the team, and for the right candidate, it could be a possibility to develop into a future role as International QA Director.

Candidate profile

  • Pharmacist, Engineer or a similar master’s degree

  • 5-10 years of experience in a specialist role, preferably with experience from contract manufacturing oversight

  • A strong quality mindset

  • Experience with aseptic, sterile manufacturing or solid dose manufacturing is an advantage

  • Ability to create strong relationships in a cross functional work environment and with external Stakeholders

  • Works independently, analytically, and systematically, but also in a collaborative approach

  • Highly motivated for solving tasks at a high and competent level

  • Strong communication skills and fluent in Danish and English



Experiences
You have a good knowledge of GMP and GDP and a minimum of 5 years of relevant experience from pharma business and QA, within one or more of the following areas:

  • Aseptic manufacturing/production of sterile drug products

  • Solid dose manufacturing

  • Investigational Medicinal Products

  • Contract manufacturing oversight

  • Auditing

  • Master manufacturing instruction and master batch document review

  • Technical transfer and/or validation tasks

  • Quality control and/or regulatory affairs

  • Risk Management/Risk Assessment



How to apply
Apply for the job and send your CV and motivation no later than 1st of June 2025 using the link on the top right side.

If you have any questions about this job before applying, please contact:
Dorthe Nilsen
Senior Director, International QA
T: +[xxxxx]Please note that all enquiries will be handled with confidentiality.

About [xxxxx]

[xxxxx] A/S is a global leader in carbohydrate chemistry and innovative treatments for iron deficiency and iron deficiency anaemia. Building on our foundational expertise in carbohydrate chemistry and cell cycle biology, we develop innovative treatments for unmet patient needs, with a focus on iron metabolism and blood-related disorders. Founded in 1965 and headquartered in Denmark, our team is made up of more than 700 specialists across the UK, Ireland, the Nordics, Germany, the USA, and China. Learn more about [xxxxx] at www.[xxxxx].com.


Information og data

Denne ledige stilling har jobtypen "Produktspecialist", og befinder sig i kategorien "Kommunikation, marketing, salg".

Arbejdsstedet er beliggende i Holbæk.

Jobbet er oprettet på vores service den 7.5.2025, men kan have været deaktiveret og genaktiveret igen.

Rapportér
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Produktspecialist
  • Holbæk
Rapportér

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