Quality Document Coordinator (Biopharmaceutical industry)
NORDIC NANOVECTOR ASA
- Frist Snarest
- Ansettelsesform Fast
Join one of Norway’s most innovative pharmaceutical companies!
Nordic Nanovector is looking for a candidate who will have specific responsibility for quality documentation and supporting the Quality Management System (QMS) as well as providing administrative support to the Quality Assurance (QA) department at Nordic Nanovector’s headquarter in Oslo.
A well-organized working style, delivering high-quality with strong attention to detail is pivotal in this role. Having previously worked in QA is not a requirement, but advantageous.
The QA document controller will have the following key responsibilities:
Documentation and Archiving:
- Ensure that all Quality related documents are created and filed correctly
- Assists with retrieving and filing of electronic records and paper QA records from CMO’s
- Works according the NANO QA procedure on document retention and archiving
- Supports functional groups with archiving activities. Arranges for documents to be logged and archived onsite and at off-site archiving facilities
- Act as the named Nordic Nanovector archivist and superuser of the company’s QMS system
SOP
- Track and maintain Master SOPs including gathering signatures and records from functional groups
- Maintain records for compliance of SOP system
- Maintain records and trackers for obsoleted SOP documents
- Provide administrative support for the QMS system
Training:
- Ensure all staff have a training record and that training documents are filed
- Regularly review training compliance for SOPs
- Help coordinate and arrange training sessions; and ensure new starters are issued with onboarding training programme and SOP training matrix
Operational QA assistant:
- Support QMS activities - follow up on deviations, Change Control for administrative related activities
- Assisting in the distribution and appropriate follow up of compliance documents internally and to external parties
- Administrative support to the QA team, SOP management
- Supporting the QA team with internal classification of documents
- Logs controlled documents coming into the QA department
What are we looking for:
- Highly organised and with excellent administrative and computer skills
- Ability to communicate with all levels with an organization
- Experience from having worked with an electronic filing system or Quality Management System is an advantage.
- A well-organized working style, delivering high-quality and with attention to detail
- Passion about working in collaborative, complex and fast-paced environment with a high sense of urgency and with the ability to “walk the extra mile”
- Committed and inspired by the mission of our company to bring safe and effective new therapies to patients.
Reporting line, location and compensation.
The position reports to the Chief Quality Officer and is based in the company’s headquarter in Oslo, Norway. Nordic Nanovector offers a challenging and exciting role in one of Norway’s most innovative pharmaceutical companies. Level of compensation will reflect experience and qualifications.
Om arbeidsgiveren
Nordic Nanovector is committed to develop and deliver innovative therapies to patients to address major unmet medical needs and advance cancer care. The Company aspires to become a leader in the development of targeted therapies for haematological cancers. Nordic Nanovector's lead clinical-stage candidate is Betalutin®, a novel CD37-targeting antibody-radionuclide-conjugate designed to advance the treatment of non-Hodgkin's lymphoma (NHL). NHL is an indication with substantial unmet medical need, representing a growing market forecast to be worth nearly USD 29 billion by 2026. Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation of Betalutin® in core markets.
Nordic Nanovector was established in Oslo in 2009 and has since March 2015 been listed on the Oslo Stock Exchange.
- Sektor: Privat
- Sted: Kjelsåsveien 168B, 0884 Oslo
- Bransje: Farmasi og legemiddel
- Stillingsfunksjon: Kvalitetssikring
Nøkkelord
Quality Assurance, QMS, Biotechnology
Annonseinformasjon
- FINN-kode 167561238
- Sist endret