Denne stilling er desværre ikke længere ledig.
Se alle ledige stillinger
København
We are looking for a QA Principal Scientist with a strong interest in IT Compliance and maintaining Data Integrity in Good Manufacturing Practice settings.
AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics and cell and gene therapies. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time.
Position Overview:
As the Principal Scientist, you will be a vital member of a highly motivated, multidisciplinary team. Your daily responsibilities will include:
- Overseeing the Quality Assurance review and approval of all IT related quality documents, including but not limited to change controls, deviations, CAPAs, risk assessments, SOPs, validation plans, requirements specifications, and qualification protocols and reports
- Driving process improvement and compliance initiatives
- Representing Quality in AGC project deliverables
- Acting as a subject matter expert during client audits, as necessary
- Communicating with internal and external stakeholders to resolve and clarify any points of issue
- Contributing to the creation of the Annual Product Quality Review (APQR), as needed
- Providing guidance and training to colleagues and stakeholders on compliance related matters
Your Profile:
It is crucial to possess a self-motivated personality with a practical approach to daily tasks, while maintaining a commitment to quality. Our working environment is dynamic and demanding, necessitating the capability to problem-solve, fulfill commitments, and provide a favorable experience for our clients.
Education and Experience:
The ideal candidate should possess the following qualifications
- A science-based Master's degree or equivalent
- Thorough understanding of Good Manufacturing Practice (GMP) principles and guidelines
- Significant experience with the qualification of GMP computerized systems (GAMP5)
- Knowledge of Data Integrity principles, and related guidelines such as CFR21 Part 11 and EU GMP Annex 11
- Prior biopharmaceutical experience is desirable
- Strong decision-making skills and a proactive attitude
- Excellent written and verbal communication skills
- Ability to work efficiently in a fast-paced, matrix environment
- Ability to meet deadlines and effectively manage multiple tasks
- Flexibility to adapt to changing business needs and priorities.
At AGC, we serve international clients and English is our company language. As such, professional proficiency in both written and spoken English is a requirement.
About The Department:
You will be joining the Quality Assurance department, consisting of over 80 colleagues, with primary responsibilities in Manufacturing, Raw Materials, Quality Control, and Facilities and Equipment.
The Quality Assurance Facilities and Equipment team is comprised of highly qualified scientists with diverse professional backgrounds and several years of experience in the field of Quality Assurance.
The main objective of the team is to ensure that our production facilities and laboratories comply with current Good Manufacturing Practice (GMP) standards, including EU GMP, 21 CFR, and ICH guidelines at all times.
The team is mainly responsible for the review and approval of quality documentation, including equipment qualifications, IQ, OQ, PQ, environmental monitoring, cleaning validation, deviation handling, and approval of CAPA and change requests.
Applications:
We continuously assess incoming applications and schedule interviews accordingly. To ensure prompt consideration, please submit your application and resume promptly.
The advertisement will be closed once the ideal candidate has been identified.
For additional information regarding the position, feel free to reach out to Volker Jentzsch, Senior Manager of QA Facilities & Equipment, at +45 2294 3062.
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 10.2.2023, men kan have været deaktiveret og genaktiveret igen.
- Forsker
- København
Lignende jobs
-
Post Doc in Historical Geobiology using high-strat...
The Dahl Group at the Section for Geology is offering a Post Doc position for an excellent, ambitious, and highly motivated candidate with background in experimental sedimentary geochemistry and re..Få mere info- Forsker
- København K
-
Postdoc of Global Nutrition and Health
Få mere info- Forsker
- Frederiksberg
-
Adjunkt eller lektor til fysioterapeutuddannelsen
Vores ambition er at uddanne fysioterapeuter, som med ansvarlighed og stærk faglighed kan træde ud og repræsentere professionen på bedste vis i samfundet. Vil du være med til at skabe forpligtende .Få mere info- Forsker
- København N
-
PhD fellowship in plant proteins and data modellin...
Department of Food Science invites applicants for a PhD fellowship in Synergizing chemistry and data science to enhance plant-based food development.Start date is 1 February 2025 or as soon as .Få mere info- Forsker
- København
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 |
|---|---|
| 26. november 2024 | 219 |
| 25. november 2024 | 227 |
| 24. november 2024 | 225 |
| 23. november 2024 | 220 |
| 22. november 2024 | 219 |
| 21. november 2024 | 225 |
| 20. november 2024 | 206 |
| 19. november 2024 | 200 |
| 18. november 2024 | 210 |
| 17. november 2024 | 215 |
| 16. november 2024 | 209 |
| 15. november 2024 | 238 |
| 14. november 2024 | 206 |
| 13. november 2024 | 223 |
| 12. november 2024 | 219 |
| 11. november 2024 | 222 |
| 10. november 2024 | 227 |
| 9. november 2024 | 231 |
| 8. november 2024 | 234 |
| 7. november 2024 | 236 |
| 6. november 2024 | 233 |
| 5. november 2024 | 226 |
| 4. november 2024 | 220 |
| 3. november 2024 | 230 |
| 2. november 2024 | 230 |
| 1. november 2024 | 249 |
| 31. oktober 2024 | 261 |
| 30. oktober 2024 | 262 |
| 29. oktober 2024 | 263 |
| 28. oktober 2024 | 266 |
| 27. oktober 2024 | 288 |
Værd at vide når du søger job som forsker i København
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.
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.
Nørrebro: Multikulturelt og kreativt med studerende, kunstnere og små startups. Populært blandt unge fagfolk og jobsøgende inden for den kreative sektor og servicebranchen.
Vesterbro: Tidligere industriområde forvandlet til et trendy sted med restauranter, barer og designvirksomheder. Tiltrækker kreative sjæle og jobsøgende inden for mode, design og underholdning.
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.
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