*QA Scientist

Denne stilling er desværre ikke længere ledig.
Se alle ledige stillinger

København

AGC QA Operations is looking for an experienced QA scientist to assist with quality assurance of microbial biotechnological production.

AGC Biologics is looking for a QA Scientist for one of our QA teams covering products produced by microbial fermentation, subsequent purification and aseptic filling of Drug Substance. The position covers QA oversight as required by GMP in a manufacturing facility mainly producing commercial grade biological APIs.

QA Operations Microbial team

QA Operations Microbial team consists of highly qualified scientists with various professional backgrounds and several years of experience within Quality Assurance.

We ensure that Manufacturing, Process Development/Transfer, Validation and Quality Control comply with the standards for cGMP production, i.e. EU GMP, 21 CFR and ICH guidelines, and you will be an important collaborator in reaching this.

The team has an open communication with focus on a high level of professionalism. We are open-minded and have a high service level to our colleagues in the rest of AGC Biologics A/S - and not least to our international customers. The QA Operations Microbial team is characterized by positive and proactive colleagues meeting deadlines through committed and friendly collaboration.

Tasks and Responsibilities
The QA Scientist provides customer service, with the highest integrity, focused on quality and compliance with partners of AGC Biologics.

Reports directly to QA Manager.

The Role (daily responsibilities):

  • Ensure resolution of quality issues together with the client through coordination and collaboration of internal functional resources to identify, propose and carry out an efficient plan to settle the issue, while protecting product quality and patient safety
  • Responsible for the overall Quality Assurance review and approval of all technical documents including but not limited to:
    • Change controls
    • Deviations
    • CAPAs
    • DS specifications
    • Master Production Records
    • Risk Assessments
    • SOPs

  • Supports deliveries related to AGC projects
  • Work with management to resolve project issues and resource constraints within the team
  • Support client audits as necessary
  • Assist with negotiation terms of Quality Agreements with the client as required
  • Liaise with the internal and external stakeholders to resolve and clarify any point of issue
  • Assist with the generation of APQR (Annual Product Quality Review), if required
  • Perform other duties as assigned

Your Profile
It is of utmost importance to have a self-motivating personality with a pragmatic attitude and approach to the daily work - without compromising quality. The environment is dynamic and challenging, which requires the ability to find solutions, deliver on promises and give our customers a positive experience.

Education and experience

  • Minimum Science based degree
  • Substantial experience working in or directly supporting manufacturing within a drug substance/product manufacturing site.
  • Previous biopharma experience is preferred.
  • Strong working knowledge of the principles and guidelines of GMP
  • Strong decision making skills and ‘can do’ attitude
  • Excellent written and verbal communication skills
  • Ability to work in a fast paced, matrix environment is essential
  • Capable of working to deadlines and prioritize multiple tasks
  • Flexibility to meet changing needs and priorities of the business

AGC has international customers and our company language is English. Professional level written and spoken English is therefore a requirement.

Want to keep posted about our growth and to learn more about our company?

We also urge you to follow us on our LinkedIn Company Page and give us a quick Like on Facebook !

AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.

Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.


Information og data

Denne ledige stilling har jobtypen "Forsker", og befinder sig i kategorien "Sundhed og forskning".

Arbejdsstedet er beliggende i København

Jobbet er oprettet på vores service den 28.12.2022, men kan have været deaktiveret og genaktiveret igen.

Rapportér
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Forsker
  • København
Rapportér

Lignende jobs

Statistik over udbudte jobs som forskere i København

Herunder ser du udviklingen i udbudte forsker i København over tid. Bemærk at jobs der ikke har en bestemt geografi ikke er medtaget i tabellen. I den første kolonne ser du datoen. I den næste kolonne ser du det samlede antal forskere i København.

Se flere statistikker her:
Statistik over udbudte forskere i København over tid

Dato Alle jobs som forskere
25. december 2024 207
24. december 2024 207
23. december 2024 228
22. december 2024 231
21. december 2024 238
20. december 2024 237
19. december 2024 233
18. december 2024 219
17. december 2024 212
16. december 2024 213
15. december 2024 220
14. december 2024 190
13. december 2024 159
12. december 2024 165
11. december 2024 214
10. december 2024 212
9. december 2024 211
8. december 2024 218
7. december 2024 220
6. december 2024 232
5. december 2024 223
4. december 2024 217
3. december 2024 221
2. december 2024 229
1. december 2024 234
30. november 2024 230
29. november 2024 235
28. november 2024 238
27. november 2024 229
26. november 2024 219
25. november 2024 227
Fold ud

Værd at vide når du søger job som forsker i København

Har du også drømt om at bo og arbejde i de charmerende gader i København? Så er du ikke alene! Men drømmene bliver sjældent til virkelighed uden lidt hårdt arbejde.

Mens København måske for nogle først og fremmest vækker billeder af hyggelige cafeer og historiske bygninger, banker et travlt erhvervsliv i hjertet af København. Hovedstaden huser et væld af brancher, men nogle skiller sig ud med et særligt højt antal ansatte.

Bydele i København

København byder på mere end smukke gader og hyggelige cafeer. De forskellige kvarterer har hver deres unikke atmosfære og erhvervsliv, hvilket kan påvirke din jobsøgning. Lad os dykke ned i nogle populære områder:

Indre By: Pulsens centrum med internationale virksomheder, finansverden og detailhandel. Perfekt for jobsøgende inden for finans, jura, medier og marketing. Tempoet er højt, og konkurrencen kan være hård.

Find ledige jobs i Indre By

Østerbro: En blanding af moderne boliger, historiske bygninger og innovative virksomheder. Hjem til Novo Nordisk og Vestas Wind Systems. Gode muligheder inden for life science, teknologi og bæredygtige løsninger.

Find ledige jobs i Østerbro

Nørrebro: Multikulturelt og kreativt med studerende, kunstnere og små startups. Populært blandt unge fagfolk og jobsøgende inden for den kreative sektor og servicebranchen.

Find ledige jobs i Nørrebro

Vesterbro: Tidligere industriområde forvandlet til et trendy sted med restauranter, barer og designvirksomheder. Tiltrækker kreative sjæle og jobsøgende inden for mode, design og underholdning.

Find ledige jobs i Vesterbro

Valby: Familievenligt og roligt med gode skoler og grønne områder. Mange offentlige institutioner og virksomheder inden for service og administration. Attraktivt for børnefamilier og jobsøgende i den offentlige sektor.

Find ledige jobs i Valby

Amager: Et område i rivende udvikling med fokus på moderne arkitektur og bæredygtighed. Hjem til Ørestad og store virksomheder som DSV og Ørsted. Gode muligheder inden for logistik, energi og transport.

Find ledige jobs på Amager

Mere information om København

Hvis du er på udkig efter et job i København, er det vigtigt, at du sætter dig grundigt ind i, hvordan jobmarkedet fungerer, og hvor i byen du vil arbejde og bo. Vi har samlet en guide med alle relevante oplysninger om København, så du kan få et samlet overblik. Læs mere om København i denne guide: København: Byen der byder på både drømmejob og spændende udfordringer

Populære søgninger

Lignende søgeresultater

Se alle populære søgninger