Manufacturing Quality Assurance Supervisor
Denne stilling er desværre ikke længere ledig.
Se alle ledige stillinger
København
Quality
The Manufacturing Quality Assurance Supervisor is responsible for daily management of quality assurance operations at the Xellia Cleveland site. The MQA Supervisor will manage the daily tasks for the applicable shift to support the manufacturing operation. The areas of responsibility for the MQA Supervisor are: On the floor Quality oversight, batch record review, logbook review, review and approval of work orders and identification of deviations. This includes collaboration, development, implementation and management of quality assurance processes, procedures and best practices. Has knowledge of Quality Assurance and Control in general and the Quality Management System (QMS) in compliance with 21CFR part 11/210/211 specifically, and requires some minimal coaching when making critical quality decisions.
Key Responsibilities
- Supervise, develop, manage and train personnel in MQA
- Quality Oversight of the manufacturing areas including batch record review, logbook review, general condition of the controlled areas and monitoring of cleanroom behaviors
- Responsible for personnel management including hiring, development and performance management
- Quality Oversight for the calibration and maintenance system
- Responsible for the authorization of SOP’s and/or qualification/validation documents
- Assist with deviations including scope, impact and associated corrective actions
- Participation in Change Control committee, evaluation and authorization of change controls
- Ensure that direct reports are current on all required training
- Collecting and reporting data for the monthly Site Governance Meeting
- Perform additional tasks in relation to quality issues as agreed with the MQA Manager
- Manage and escalate Quality issues to the MQA Manager
Requirements
- B.S. in Physical Science or Engineering or equivalent experience
- Minimum of 3 years industry experience
- A good knowledge of various GMP compliances regulations and industry practices
Ability to critically evaluate and troubleshoot complex problems is essential - Ability to effectively participate on multi-disciplinary teams
- Ability to absorb, digest and relate detailed scientific, quality, and regulatory information
- Well-organized and detailed oriented professional, with strong verbal and written communication skills
Physical Requirements of the Role
- Position is exposed to a number of environments, office, lab, outside, plant floor, etc. This role is continuously sitting and typing. Frequently talking and using eye and hand coordination. Occasionally requiring lifting and carrying less than 10 lbs. Standing, walking, bending over, and repetitive use of legs are done occasionally.
Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions that may adversely affect the safety or quality of drug products shall be excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of drug products. All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products.
Xellia Pharmaceuticals is owned by Novo Holding A/S and is a specialty pharmaceutical company leading in the development, manufacture and supply of anti-infective treatments. Headquartered in Copenhagen, Denmark, Xellia has global facilities in Europe, North America, and Asia, currently employing over 1700 people. With over 100 years of industry experience in developing last resort treatments for infectious diseases, Xellia is focused on the supply of products which not only save lives, but also improve and enhance patients’ quality of life. Together with us, you can help lead the fight against bacterial infections.
Read more about Xellia Pharmaceuticals here
Information og data
Denne ledige stilling har jobtypen "Produktchef", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 22.11.2021, men kan have været deaktiveret og genaktiveret igen.
- Produktchef
- København
Lignende jobs
-
Product Owner - [xxxxx] Pension
Job ID: 22619 Vil du være med til at udvikle [xxxxx]s pensionsforretning? Trives du i et miljø med mange opgaver, som du enten har det fulde ansvar for eller er en del af? Så er dette job noge..Få mere info- Produktchef
- København S
-
Senior Engineering Manager
Description As a Senior Engineering Manager, you ll lead a high-performing, distributed engineering team focused on enhancing our SaaS platform. Your leadership will drive the development of scal..Få mere info- Produktchef
- København K
-
Internship: Procurement Technology, Sustainability...
About [xxxxx]We operate a transport network in and around Europe with an annual revenue of DKK 30bn and 17,000 full-time employees.We move goods in trailers by ferry, road & rail, and we off..Få mere info- Produktchef
- København Ø
-
Konsulent - Public Procurement & Contracts
Få mere info- Produktchef
- København S
Statistik over udbudte jobs som produktchef i København
Herunder ser du udviklingen i udbudte produktchef 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 produktchef i København.
Se flere statistikker her:
Statistik over udbudte produktchef i København over tid
| Dato | Alle jobs som produktchef |
|---|---|
| 25. december 2024 | 22 |
| 24. december 2024 | 23 |
| 23. december 2024 | 23 |
| 22. december 2024 | 22 |
| 21. december 2024 | 22 |
| 20. december 2024 | 22 |
| 19. december 2024 | 22 |
| 18. december 2024 | 23 |
| 17. december 2024 | 23 |
| 16. december 2024 | 24 |
| 15. december 2024 | 27 |
| 14. december 2024 | 26 |
| 13. december 2024 | 31 |
| 12. december 2024 | 25 |
| 11. december 2024 | 25 |
| 10. december 2024 | 25 |
| 9. december 2024 | 23 |
| 8. december 2024 | 24 |
| 7. december 2024 | 24 |
| 6. december 2024 | 24 |
| 5. december 2024 | 24 |
| 4. december 2024 | 26 |
| 3. december 2024 | 25 |
| 2. december 2024 | 22 |
| 1. december 2024 | 21 |
| 30. november 2024 | 22 |
| 29. november 2024 | 24 |
| 28. november 2024 | 23 |
| 27. november 2024 | 22 |
| 26. november 2024 | 25 |
| 25. november 2024 | 25 |
Værd at vide når du søger job som produktchef 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