Scientist – Supplier Quality Management

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

København

About the Role

As part of the Supplier Quality Management team, you’ll be responsible for executing the company’s supplier quality program and supporting a site manufacturing clinical and commercial drug substance. You’ll perform supplier evaluations, lead supplier audits, and support the site as a subject matter expert during audits and inspections. This role requires attention to detail, organization, and comfort interacting cross-functionally with internal and external partners.

About the team Quality Systems

Quality Systems is an important part of the Quality organization. You will be joining a diverse team of eleven highly qualified colleagues, all with several years of experience within quality assurance.

The Quality Systems team is responsible for maintenance and development of our quality systems for deviation, CAPA, change management, training management, and document control. We also have oversight of the supplier qualification program, internal and external audits, regulatory inspections, and customer quality agreements.

We are also actively involved in the constant development and improvement of the quality system and our facility in Søborg.

The team works closely together with the Quality Operations team, and routinely collaborates with partners across all functional areas at the site, to ensure all quality-related activities are carried out effectively, efficiently, and in compliance with cGMP. We keep an open communication with focus on a high level of professionalism. We are open-minded and committed to providing high-quality service to our colleagues in the rest of AGC Biologics and – and to our customers, as well.

Responsibilities

  • Execute the ACG Biologics Approved Supplier Program for the site.
  • Help develop the annual audit schedule.
  • Schedule and perform audits with suppliers (including contract laboratories).
  • Manage timely performance and closure of outsourced audit (i.e. audits conducted via consultants and other internal qualified resources).
  • Manage supplier CAPA follow-up (as part of management of the audit response).
  • Facilitating initial and lifecycle supplier qualification assessments.
  • Manage the site’s Approved Supplier List.
  • Act as supplier point-of-contact for quality-related topics.
  • Optimize the Supplier Quality program through management of or participation in continuous improvement projects.
  • Support customer audits and regulatory inspections as a Subject Matter Expert for Supplier Quality.

Candidate Profile

  • Masters Degree or PhD in pharmacy, biochemistry, or related life sciences field.
  • Minimum five years prior working experience in a Biotech/Pharmaceutical production environment, preferably with focus on supplier quality.
  • Strong knowledge of GMP guidelines, as well as international regulations, pertaining to the production of biopharmaceutical products (including, but not limited to 21 CFR Parts 11, 210, 211, 600, and 610; EU GMP Parts I, II, and III, and relevant ICH guidelines).
  • Proven technical writing skills.
  • Proven ability to perform supplier audits.
  • Skill in verbal communications. Ability to respond to complex inquiries from customers, co-workers, and supervisors regarding products and processes.
  • Strong knowledge of Quality Assurance concepts related to supplier management activities.
  • Skilled in time and priority management. Must be able to work under general direction to complete work tasks.
  • Demonstrated ability to work collaboratively to accomplish deadlines and objectives.

AGC offers

AGC offers a dynamic working place with good opportunities of working with a varied array of tasks and challenges. You will get insight into and experience with the way the various departments throughout a contract manufacturing organization interact in order to achieve success. Exciting and challenging assignments will constantly come your way, and you will to a large extend be able to plan your daily work yourself. AGC offers an informal working environment, where humor is part of the daily work life. We respect each other and our individual differences. AGC’s employees have a flexible attitude and we help each other to reach deadlines together as one team.

Application
Submit your application as soon as possible. We treat the applications as we receive then, and conduct interviews with qualified candidates. When the right candidates are found, the ad will close.

Want to keep posted about our growth and to learn more about our company?
We also urge you to follow us on ourLinkedIn 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 11.2.2022, 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
16. september 2024 229
15. september 2024 274
14. september 2024 262
13. september 2024 272
12. september 2024 247
11. september 2024 253
10. september 2024 246
9. september 2024 249
8. september 2024 238
7. september 2024 244
6. september 2024 248
5. september 2024 246
4. september 2024 244
3. september 2024 236
2. september 2024 228
1. september 2024 253
31. august 2024 266
30. august 2024 264
29. august 2024 257
28. august 2024 262
27. august 2024 271
26. august 2024 254
25. august 2024 252
24. august 2024 248
23. august 2024 254
22. august 2024 239
21. august 2024 256
20. august 2024 241
19. august 2024 239
18. august 2024 225
17. august 2024 233
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