GMP Documentation Coordinator

2 days ago


Hillerød, Hillerød Kommune, Denmark Fujifilm Diosynth Biotechnologies Full time

About the Company

Fujifilm Diosynth Biotechnologies is a leading Contract Development and Manufacturing Organization (CDMO) that enables the success of innovative biotech and biopharma companies. We have a strong commitment to diversity, inclusion, and sustainability, and we strive to foster a collaborative and rewarding work environment.

About the Role

We are seeking a highly motivated and detail-oriented individual to join our Drug Substance Manufacturing Support team as a GMP Documentation Coordinator. As a key member of our team, you will play a critical role in supporting manufacturing operations with project management and compliance of procedures and documentation.

Key Responsibilities:

  • Coordinate different types of documents for DSM.
  • Issue documents and labels for DSM.
  • Review BPRs and logbooks.
  • Create and maintain records and procedures by collecting information from stakeholders.
  • Perform timely closure of action items to ensure reliable execution of production.
  • Continuous improvement of department processes and support of stakeholder improvement projects.

Qualifications and Skills

We are looking for a responsible, conscientious, and proactive individual who is ready for professional development. You should be able to navigate on your own, in a team, and among many stakeholders.

Requirements:

  • Experience with cGMP and pharmaceutical manufacturing, preferably 2-5 years in the industry.
  • Educational background in engineering, science, pharmacy, or similar field.
  • Knowledge about Cell Culture and Purification unit operations.
  • Fluency in English language.

About Us

We offer a competitive compensation package, opportunities for professional and personal development, and a chance to be part of a global workplace where passion, drive, and commitment are met with opportunities for growth. We are committed to fostering a diverse and inclusive work environment and promoting equal opportunities for all employees.



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