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GMP Training Specialist (Biopharmaceuticals, Remote)

Copenhagen, Capital Region
Posted 2 months ago
Education and Training

About the role

Job summary

The GMP Training Specialist plays a crucial role in enhancing the training and onboarding processes for Manufacturing & Engineering teams, ensuring compliance with GMP standards and fostering a culture of continuous improvement.

Qualifications

  • 3–5 years of relevant experience in GMP manufacturing or a related training role.
  • Strong knowledge of biopharmaceutical GMP processes and training requirements.
  • Excellent organizational skills with attention to detail, ensuring compliance with Good Documentation Practices (GDocP) and ALCOA+ principles.
  • Understanding of adult learning principles and their application in training design and delivery.
  • Familiarity with TWI (Training Within Industry) and LEAN methodologies is preferred.
  • Proficient in English; knowledge of Danish is a plus.
  • Experience with Office 365 and digital learning tools like Articulate 360.

Responsibilities

  • Provide support to employees regarding training systems, documentation, and onboarding activities.
  • Ensure training documentation and LMS records are accurate and compliant with GMP standards.
  • Facilitate engaging onboarding programs for new employees.
  • Create and update GMP training materials, eLearning content, and job aids.
  • Collaborate with management and training colleagues to identify training needs and enhance competency frameworks.
  • Deliver classroom and practical training sessions on GMP fundamentals and related topics.
  • Utilize TWI methodology to promote consistent standards and effective on-the-job training.

Skills

  • Strong communication and interpersonal skills.
  • Proactive, structured, and service-oriented mindset.
  • Ability to thrive in a fast-paced environment while maintaining high-quality standards.

Education

  • Relevant educational background in a related field is preferred.

Tools

  • Proficient in Office 365 and digital learning platforms such as Articulate 360.
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