Quality Assurance in Curida Diatec, one of Norway's most exciting biotechnology companies
- Curida Diatec
- Quality Assurance Specialist
As member of the Quality Assurance team you will:
Maintain and drive continuous improvement of Quality Management System (QMS) processes to ensure manufacturing quality is maintained while efficiency is optimized.
Support the organization’s departments to secure quality in their work, by daily operations of document management related to production, facility management, logistics processes and Quality Control (QC).
Handle complaints, deviations, and Corrective and Preventive Actions (CAPA). Provide guidance for investigation of compliance issues and implementation of efficient CAPAs.
Support handling of Change Controls and Risk Management.
Review, approve and authorize quality documents.
Support validation and qualification of processes and analytical methods, equipment and facilities.
Take responsibility for quality deliverables in the organization and monitoring of regulatory compliance using relevant tracking tools.
Improve and maintain a quality mind set in the organization, communicate relevant improvements required to the management and implement changes in the Quality Management System.
Perform Internal and external audits.
Develop the ability to interpret and apply relevant regulations consistently.
Continuously develop the quality competence, on a personal level, in the quality assurance team and the rest of the company.
Competence and experience criteria for the position:
Master’s degree in Science or Pharmacy.
Several years’ experience within relevant QA roles in biotech or pharmaceutical industry.
QA experience related to QMS management, regulatory inspections, and Contract Manufacturing Organizations (CMO) is an advantage.
Experience and good knowledge of GMP guidance, ISO 9001, and local regulations.
Technical experience of production processes and equipment is an advantage.
Skill set requested:
Highly organized, efficient and with an excellent attention to details as well as ability to see the bigger picture.
Good communication skills, with high proficiency in written and verbal English. Our documents are in English, but we expect Norwegian/Scandinavian to be understood and spoken.
Hands-on skills necessary to plan and execute own work in a time efficient manner, ability to work independently while embrace working in a team.
Ability to prioritize workload and meet strict deadlines.
Good decision-making and problem-solving skills.
Committed and inspired by the mission of our company to bring safe and new therapies to the patients.
Curida Diatec is a pioneer in the Norwegian biotech industry, GMP-certified for manufacture of biologics in Norway. As a Contract Development and Manufacturing Organization (CDMO) specializing in monoclonal antibodies, we service both the diagnostics and therapeutics industries.
Curida Diatec has over 30 years of experience in the production of monoclonal antibodies. Our customers range from academic research departments and startups to global diagnostics and pharmaceutical companies.
Curida Diatec employees come from over 10 countries. We see our multicultural work environment as a huge competitive advantage.
The Quality Assurance team work at both Curida Diatec's facilities at Oslo Science Park and Technopolis.
- Oslo Science Park, Gaustadalleen 21, 0349 Oslo - and - Technopolis, Martin Linges vei 25, 1364 Forne, 0349 Oslo
- Delvis hjemmekontor
- Farmasi og legemiddel,
- Forskning, utdanning og vitenskap,
- Kjemisk industri
- Revisjon og kontroll,
Quality, QA, pharma, biotechnology, regulatory
Spørsmål om stillingen
- Anna Huk
- Head of Quality
- 459 66 766
Oslo Science Park, Gaustadalleen 21, 0349 Oslo - and - Technopolis, Martin Linges vei 25, 1364 Forne, 0349 Oslo
|Sist endret||1. mai 2023 14:08|