Autosøk
FINN-kode: logo

Rådgiver - adm

FINN-kode:

Ullernchausseen 70, 0379 Oslo

Stillingsbeskrivelse

ACT is a core facility resource situated at Oslo University Hospital, the Radium hospital, under the Section for Cell Therapy. The primary goal of the ACT center is to facilitate the development of novel advanced therapy medicinal products (ATMP) and make novel therapies available to Norwegian patients. Through a single entry point, ACT will support and guide clients through the required steps from research product to a quality assured product for use in clinical trials. This involves facilitating regulatory issues, process development, process validation, agreements, financing etc.

At the Center for Advanced Cell Therapy (ACT) there is a vacancy for a temporary position as QA/QC advisor. The position is available for 12 months, with the possibility of extension. The QA/QC advisor will support the ATMPs process development and manufacturing within the Section of Cell Therapy.

Work assignments

  • Participate in ensuring that all production processes are controlled and monitored for quality.
  • Various analysis and quality control tasks related to the release of products.
  • Co-responsibility for qualification, follow-up, maintenance and documentation of various instruments and equipment in QC.
  • Responsibility for microbiological methods and procedures.
  • Participate in the development and updating of analysis methods.
  • Carry out a receiving inspection against established specifications before the item is approved for use in production.
  • Responsible for training qualified personnel for delegated responsibilities.
  • Carry out other tasks against the section's quality system, such as trending/follow-up of deviations, change control, writing/revision of procedures and methods.
  • Participate in other types of daily tasks and projects as needed.

Krav

  • Authorized bioengineer, pharmacist or equivalent relevant education.
  • 3-5 years of experience in laboratory work.
  • Experience from quality control work within the pharmaceutical industry, biotechnology or similar.
  • Knowledge/experience with GMP work and quality systems.
  • Must be fluent in Norwegian (or a Scandinavian language) and English in writing and orally.

Ferdigheter

Quality Control (QC)Quality Assurance (QA)GMP (Good Manufacturing Practice)Microbiological analysisDeviation handlingCAPAChange controlQuality risk management

Erfaring

mid-level

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