Senior Scientist, Quality Assurance Specialist

1 week ago


Copenhagen, Copenhagen, Denmark AGC Inc Full time

Our Mission:

At AGC Inc., our mission is to work side-by-side with our clients and partners to improve patients' lives by bringing new biopharmaceuticals to market. We strive to be the partner of choice in the industry, known for our commitment to quality, innovation, and customer satisfaction.

The QA Operations Department:

The QA Operations department is expanding, and we are looking for a Senior Scientist to join the QA Mammalian team. This team is responsible for ensuring the quality of our biotechnological production, working closely with scientists and principal scientists with various professional backgrounds and years of experience.

Role & Responsibilities:

  • Ensure resolution of significant quality issues through coordination and collaboration of internal functional resources.
  • Responsible for the overall Quality Assurance review and approval of technical documents.
  • Support the generation of new SOPs and improvement of existing ones.
  • Support delivery of AGC projects and work with management to resolve project issues.
  • Support client audits and assist with negotiation terms of Quality agreements as required.
  • Liaise with internal and external stakeholders to resolve and clarify any point of issue.
  • Assist with the generation of APQR (Annual Product Quality Review).

Required Skills and Qualifications:

  • A Master's degree in a relevant Science field.
  • A minimum of 3-5 years of relevant GMP experience.
  • Strong decision-making skills and a 'can-do' attitude.
  • Ability to work in a fast-paced, matrix environment.
  • Excellent written and verbal communication skills.
  • Fluent in written and spoken English.


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