Senior Quality Assurance Professional for Change Management

2 months ago


Hillerød, Hillerød Kommune, Denmark FUJIFILM Diosynth Biotechnologies Full time

We are seeking an experienced Senior Quality Assurance Professional to join our Quality Control Change Management team at Fujifilm Diosynth Biotechnologies Denmark. Located in Hillerød, our company is a leading Contract Laboratory Organization (CLO) with a strong commitment to quality and compliance.

As a Senior Quality Assurance Professional, you will be responsible for managing QC change records, coordinating changes to quality processes, and ensuring GMP documentation is maintained in collaboration with stakeholders and QA teams. You will work closely with cross-functional teams and external partners to drive process optimization and identify areas for improvement.

This role offers an exciting opportunity to contribute to the growth and expansion of our site, driving innovation and excellence in quality assurance.

Key Responsibilities:

  • Manage QC change records and ensure timely completion
  • Coordinate changes to quality processes and document results
  • Maintain GMP documentation in collaboration with stakeholders and QA teams
  • Work closely with cross-functional teams and external partners to drive process optimization

Requirements:

  • Experience in cGMP and pharmaceutical manufacturing
  • Strong understanding of GMP regulations and guidelines
  • Excellent communication and collaboration skills
  • Ability to work independently and as part of a team
  • Proficiency in English; Danish proficiency is a plus but not required

What We Offer:

  • A competitive salary: DKK 1,200,000 - DKK 1,500,000 per annum, depending on experience
  • Benefits including health insurance, massage and physiotherapy, health checks, and fitness center
  • Remote work options
  • Amenities like a mobile barista coffee van and canteen services


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