QUALITY ASSURANCE MANAGER

ViCapsys is a privately-owned biotechnology company that is developing innovative products for cell therapy in diabetes.

Main activities and responsibilities

  • Be aware of the regulatory requirements (GMP, GCP,  etc) relevant to cell therapy product development and ensure compliance with the regulations
  • Manage quality assurance activity as per good lab practices (GLP) standards, handling documentation and records
  • Review, monitor, and control the activities, preparation of standard operating procedures (SOPs)
  • Conduct training of ViCapsys personnel on quality assurance
  • Review test procedures and test reports
  • Efficiently monitor documentation and records for all laboratory activities (installation, calibration, assay development, transfer, qualification/validation and implementation of the assays in clinical trials studies in accordance with current GLP guidelines and industry standards for such assays)
  • He/She should be interested and should have aptitude in learning ways of documentation and in record maintaining

 

Education and experience

  • B.Sc. or M.Sc. in Immunology/cell biology/molecular biology with 3-5 years of relevant industry experience in a related field is required.
  • Experience with processes/guidelines related to GLP/GCP compliance procedures and a guideline is necessary.

 

Personal skills

  • Great sense of responsibility and commitment
  • Team player with strong communication skills
  • Well-organized; well-developed time, task and project management skills
  • Goal oriented and strong critical and analytical thinking
  • Attention to detail and always striving for high quality
  • A dynamic, positive approach; pro-active; flexible; eager to learn
  • Able to work independently and to manage multiple and varied tasks
  • Very good knowledge of English (spoken and written)

 

Opportunities:

  • A full-time position, available immediately
  • A challenging job in a dynamic and enthusiastic work environment
  • Individual training and personal development opportunities
  • A competitive compensation package

 

Contact: Jessica Hutcheson; jhutch@vicapsys.com