Do you want to work with QA in one of Norway's most exciting biotech companies?
- Arbeidsgiver
- Diatec Monoclonals AS
- Stillingstittel
- Quality Assurance Specialist
- Frist
- 10.01.2022
- Ansettelsesform
- Fast
We are searching for a Quality Assurance Specialist for our GMP site at Oslo Science Park.
Responsibilities includes but are not limited to:
- Daily operations of document management for the GMP production and QC, issuing, reviewing, approving, authorizing and archiving controlled documents like SOP’s, MBR’s ENC’s, labels, log books
- Drive continuous improvement of core processes to ensure manufacturing quality is maintained while efficiency is optimized
- Perform Internal audit and self-inspection
- Handle deviation, change controls and CAPAs
- Responsible for quality deliverables in the Diatec GMP organization, support monitoring of regulatory compliance using relevant tracking tools
- Spearhead for improving and maintaining a quality mind set the organization, communicate relevant improvements required to the management, implement changes in the QMS following established routines as agreed
- Responsible for continuous quality competence development, on a personal level as well as supporting the quality assurance team and the rest of the company.
Competence and experience criteria for the position:
- Master’s degree in Science or Pharmacy
- Experience from working in the pharmaceutical or biotech/biopharma industry
- Experience from GMP and Quality Management System processes.
- Experience with analytical QA, regulatory inspections, and working with Contract Manufacturing Organizations (CMO) is an advantage.
Skill set requested:
- Highly organized, efficient and with an excellent attention to details.
- Good communication skills, with high proficiency in written and oral 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.
- Committed and inspired by the mission of our company to bring safe and new therapies to the patients.
With Diatec you will be a part of an exciting adventure that will develop you professionally as you are building a growing innovative and dynamic biotech company with us.
Diatec is committed to create an inclusive work environment and diverse team with different backgrounds and nationalities. Today we have employees from over 15 countries, including Brazil, France, Iceland, Ireland, Italy, Nepal, Sri Lanka, Sweden, Thailand, Uganda, Vietnam and USA. We see our multicultural work environment as a huge competitive advantage.
Om arbeidsgiveren
Diatec Monoclonals is a pioneer in the Norwegian biotech industry, and we are the only GMP-certified biologics manufacturer in Norway. As a CMO specializing in monoclonal antibodies, we service both the diagnostics and therapeutics industries and we have over 25 years of experience with production of monoclonal antibodies. Our customers range from academic research departments and startups to global diagnostics and pharmaceutical companies.
- Nettverk
- Sektor
- Privat
- Sted
- Gaustadalléen 21, 0349 Oslo
- Bransje
- Farmasi og legemiddel,
- Industri og produksjon,
- Annet
- Stillingsfunksjon
- Kvalitetssikring,
- Annet,
- Helsepersonell / Farmasøyt
Nøkkelord
QA, QMS, GMP, Farmasi, Farmasøyt
Spørsmål om stillingen
- Kontaktperson
- Truc Thi Røgeberg
- Stillingstittel
- Quality Director
- Mobil
- 40 91 13 10
- Kontaktperson
- Mira H Børstad
- Stillingstittel
- Site Manger ISO
- Nettverk
Gaustadalléen 21, 0349 Oslo