*QA Compliance Lead, Facilities and Equipment

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

København

Would you like to be a part of AGC Biologics’ growing success?

We are seeking a highly motivated and experienced QA Compliance Lead to join our team. In this role, you will be responsible for ensuring GMP (Good Manufacturing Practices) compliance for our facilities and equipment. You will play a critical role in ensuring the quality and safety of our products, while ensuring that our operations comply with relevant regulations and standards.

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 QA Compliance Lead, you will be a vital member of a highly motivated, multidisciplinary team. Your daily responsibilities will include:

  • Develop and implement GMP policies and procedures to ensure compliance with industry standards and regulations
  • Identify and evaluate potential compliance risks, and develop and implement corrective actions to mitigate these risks
  • Maintain up-to-date knowledge of industry regulations and standards, and communicate relevant changes to relevant stakeholders
  • Collaborate with cross-functional teams to ensure that GMP compliance is integrated into all aspects of operations, from design to manufacture
  • Train and educate employees on GMP compliance requirements and best practices

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
  • At least 5 years of experience in a GMP-regulated environment, with a focus on compliance and quality assurance
  • Strong knowledge of GMP regulations and standards, including FDA 21 CFR 210/211
  • Knowledge of Data Integrity principles, and related guidelines such as CFR21 Part 11 and EU GMP Annex 11
  • Excellent communication and interpersonal skills, with the ability to effectively communicate with cross-functional teams and stakeholders
  • Strong problem-solving skills, with the ability to identify and evaluate potential compliance risks and develop effective solutions
  • 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 "Finansmedarbejder", og befinder sig i kategorien "Økonomi og jura".

Arbejdsstedet er beliggende i København

Jobbet er oprettet på vores service den 8.2.2023, 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.
  • Finansmedarbejder
  • København
Rapportér

Lignende jobs

Statistik over udbudte jobs som finansmedarbejdere i København

Herunder ser du udviklingen i udbudte finansmedarbejder 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 finansmedarbejdere i København.

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

Dato Alle jobs som finansmedarbejdere
7. november 2024 65
6. november 2024 66
5. november 2024 65
4. november 2024 65
3. november 2024 63
2. november 2024 62
1. november 2024 63
31. oktober 2024 68
30. oktober 2024 62
29. oktober 2024 61
28. oktober 2024 62
27. oktober 2024 61
26. oktober 2024 63
25. oktober 2024 69
24. oktober 2024 68
23. oktober 2024 69
22. oktober 2024 67
21. oktober 2024 64
20. oktober 2024 69
19. oktober 2024 70
18. oktober 2024 67
17. oktober 2024 68
16. oktober 2024 68
15. oktober 2024 62
14. oktober 2024 64
13. oktober 2024 68
12. oktober 2024 68
11. oktober 2024 68
10. oktober 2024 66
9. oktober 2024 64
8. oktober 2024 66
Fold ud

Værd at vide når du søger job som finansmedarbejder 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