Exciting QA position - do you want to shape tomorrows QA in Norwegian Biotech?
- Oncoinvent AS
- QA Officer/Electronic Document System Administrator
Quality Assurance Officer/ Electronic Document System Administrator
Oncoinvent is growing and moving forward with their clinical trials and is now in need of a Quality Assurance Officer with particular interest in quality systems and regulated electronic systems.
The QA Officer will support Oncoinvent’s organization in being compliant to applicable regulations and guidelines, such as Good Manufacturing Practice, Good Laboratory Practice, Good Distribution Practice and Good Clinical Practice by working closely with colleagues from the different departments.
As a company in a highly regulated industry, there is also need for a person who is interested in working with computerised systems, both hands on as support to the organisation and from a high-level view, ensuring that systems are kept in their validated state.
Oncoinvent will ensure that the right candidate will receive the training and guidance required to perform the tasks of the position.
The company prides itself with an inclusive working environment with a shared vision, in new modern facilities in Nydalen in Oslo, close to the sub way station.
- Reviewing and approving SOPs, analytical methods, qualification protocols and reports, etc.
- Following up and supporting Oncoinvent’s organization in the handling of deviations, CAPAs and Change Controls.
- Function as administrator of the electronic document system, handle day-to-day issues in the system, support users, train users and ensuring that the system is in a validated state.
- Participate as QA representative in various projects
- Support any manual document handling and archiving
- Contribute to internal inspections and vendor/supplier assessments
Qualifications and experience:
The holder of this position should have the following documented qualifications and experience:
- MSc in Pharmacy or other relevant natural sciences
- Experience from pharmaceutical- or other relevant highly regulated industries is desired, but not a requirement. New graduates will also be considered.
- Skilled in the use of Word, Excel or other similar applications
- Fluent in oral and written English and preferably working knowledge in Norwegian
We are furthermore looking for a candidate with an interest and/or experience in:
- working with quality systems and/or document handling
- working with electronic systems that have strict regulated functionalities
- A successful candidate will further have to be able to work in a multidisciplinary team displaying a systematic and analytical approach while being able to plan and perform tasks completing them on time. The successful candidate should have excellent communication skills and be instrumental in driving change in the QA department.
The holder of this position will be based at Oncoinvent AS, Gullhaugveien 7, 0484 Oslo. The position will report to the Head of QA.
Application deadline: N/A
Please submit your application with a motivational letter stating “why Oncoinvent” and what you can contribute to the position as well as an updated CV. Application without this will not be reviewed further.
Oncoinvent is a privately held Norwegian company based in Nydalen, Oslo. The company is committed to developing novel, innovative products to provide better treatment options for cancer patients.
The Oncoinvent team consists of 33 employees and the company anticipates further growth.
In December 2017 Oncoinvent finished building a state-of-the-art manufacturing facility to produce drug product intended for use in pre-clinical and clinical trials. Clinical trials for Oncoinvent’s lead product, Radspherin®, started in 2020. For further details on Oncoinvent see www.oncoinvent.com.
The facility received a GMP certificate from the Norwegian Medical Agency in February of 2019. The approval provides the company with the necessary flexibility and capacity for manufacturing clinical trial material for both patients and trial sites, as well as developing the company further.
The company’s lead product candidate Radspherin® is a novel alpha-emitting radioactive microsphere suspension designed for treatment of micro-metastatic cancers in body cavities. The radium-224 based therapeutic, Radspherin® has shown strong and consistent anticancer activity at doses being essentially non-toxic in preclinical studies. It is anticipated that the product can potentially treat several forms of micro-metastatic cancer.
Farmasi, Produksjon, Kvalitetssikring, Dokumentsystemer, Kvalitetssystemer
|Sist endret||15. sep. 2021 09:32|