QA /QC advisor

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.

Oslo University Hospital is a workplace with very good opportunities for both professionally and personally development. To be able to meet the challenges of today and the future, we need skilled and committed people co-workers. We are a developing workplace that will look after both patients, relatives
and employees, and in that way we can live up to our vision; "Together with the patients, we create tomorrow treatment".

Oslo University Hospital is a workplace with great diversity. We believe that is absolutely crucial to solving the tasks required from us. We therefore want this diversity to be reflected among our applicant’s positions and encourage everyone to apply regardless of who you are and what background you have.

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.
• Other tasks may become relevant depending on background/experience and ongoing projects.
• Collaborate closely and actively with the operations manager, the production managers for the various cell therapy programs and their deputies, as well as with other employees in the department and collaborating departments.

Qualifications

• 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.
• Experience within Quality Assurance in a GMP-regulated environment.
• Experience with deviation handling, CAPA, change control, and quality risk management.
• Competence and experience within microbiological analyses.
• Good understanding of and experience with relevant analytical equipment instruments and methods.
• Must be fluent in Norwegian (or a Scandinavian language) and English in writing and orally.

We request that relevant documentation be attached to the application.

Personal characteristics

With us, it is important that you:

• have the ability to collaborate across different professional groups.
• can work independently.
• can work in a targeted, structured and solution-oriented manner.
• have good analytical skills.

We offer

• A safe workplace with good colleague support.
• Good opportunities for professional and personal development.
• As a new employee in OUS, you become part of a new employee program.
• Salary by agreement within OUS's collective agreements.

Do you want to know more about us?https://www.oslo-universitetssykehus.no/om-oss/jobb-og-utdanning/arbeidsplassen-var