Denne stilling er desværre ikke længere ledig.
Se alle ledige stillinger
København
Quality
The MQA Specialist I is responsible for providing quality oversight to all manufacturing and packaging areas to ensure product quality and SOP/GMP compliance at the Cleveland Manufacturing Facility. This individual will works closely with production personnel to complete on-the-floor, in process batch record review, resolve all batch related issues or escalate to the Quality Assurance Supervisor as appropriate while ensuring good documentation practices are being followed. The MQA Specialist I should be someone who may require direct guidance and supervision on a daily basis.
Key Responsibilities
- Required to be on the floor and present to provide quality oversight for all critical manufacturing processes
- Required to become and maintain gown qualification
- Required to become and maintain AQL Visual Inspection Qualification
- Works closely with MQA supervision as needed
- Demonstrates an ability to multitask in a proficient manner
- Addresses daily quality concerns and questions related to operating and environmental issues
- Clearly communicates complex issues to Management personnel
- Work closely with Production personnel to complete in-process batch record review, resolve batch related issues with guidance from MQA Supervision
- Assist in analysis of inspection rejects; assist in root cause analysis and implementation of CAPAs
- Perform and document assessments of aseptic behavior inside the aseptic manufacturing area during filling, capping, and lyophilizer loading/unloading activities. Provide real time aseptic technique coaching and risk mitigation in the event of an aseptic technique violation
- Complete monthly inspections of the physical conditions of the manufacturing support areas and report issues to MQA supervision
- Provide regular updates about aseptic behaviors to the production department, support groups and site leadership
- Participation in gathering of data needed for the Annual Product Review
- Collecting of data for Quality Monthly Report
- Perform additional tasks in relation to quality issues as assigned with the Quality Assurance Supervisor
- Equally split time between under desirable conditions of the office setting and exposure to moderately disagreeable features of noise, heat or production conditions
- Ensure processes and products are in compliance with all local, state, and federal rules and regulations. Oversee that processes are in CGMP compliance, and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality. Develop knowledge of and understand regulatory requirements such as 21CFR part 210 and 211, cGMP’s, FDA, OSHA and other regulatory agencies.
- Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.
- The primary focus of the MQA Specialist I covers the following areas: On Floor oversight in Manufacturing and Packaging areas, Incoming Material Inspection, Review of batch records and packaging records
Qualifications:
- B.S. in Life or Physical Science with one (1) to five (5) years or equivalent education/professional experience
- Knowledge of a GMP production facility and/or inspection processes required
- Ability to critically evaluate and troubleshoot complex problems and articulate clearly to management is essential
- Well-organized and detailed oriented professional, with strong verbal and written communication skills
- Quality or Pharmaceutical certifications is a plus
Physical Requirements of the Role
Position is exposed to a number of environments, office, lab, outside, plant floor, etc. 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 a specialty pharmaceutical company developing, manufacturing and commercializing anti-infective treatments against serious and often life-threatening bacterial and fungal infections. Headquartered in Copenhagen, Denmark, Xellia has a global footprint with R&D, manufacturing and commercial operations across Europe, Asia, the Middle East and North America. Xellia is wholly owned by Novo Holdings A/S and employs a dedicated team of over 1,800 people.
With over 115 years of experience, Xellia is a world-leading trusted supplier of several important established anti-infective drugs, comprising active pharmaceutical ingredients as well as injectable products. Continuing the Company’s evolution, Xellia is generating an innovative pipeline of value-added anti-infective medicines intended to enhance patient care, providing convenience and ease of use for healthcare professionals.
Together you can help us lead the fight against infections.
Further information about Xellia can be found at: www.xellia.com
Connect with us on LinkedIn
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
-
Internship: Procurement Technology, Sustainability...
We are a transport and logistics company providing the safe, reliable and efficient movement of people and goods - more than 12,000 colleagues, all committed to transforming our business into a gre..Få mere info- Produktchef
- København Ø
-
Service Delivery Manager
Hvis du godt kan tænke dig at arbejde med innovative digitale løsninger inden for energi og grøn omstilling – og samtidigt gerne spille en vigtig rolle i at sikre stabil drift og mindre udvikling i..Få mere info- Produktchef
- København S
-
Product Owner – Control Tower T&I
We are a transport and logistics company providing the safe, reliable and efficient movement of people and goods - more than 12,000 colleagues, all committed to transforming our business into a gre..Få mere info- Produktchef
- København Ø
-
Product Owner – Vessel T&I
We are a transport and logistics company providing the safe, reliable and efficient movement of people and goods - more than 12,000 colleagues, all committed to transforming our business into a gre..Få mere info- Produktchef
- København Ø
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 |
|---|---|
| 27. november 2024 | 22 |
| 26. november 2024 | 25 |
| 25. november 2024 | 25 |
| 24. november 2024 | 25 |
| 23. november 2024 | 25 |
| 22. november 2024 | 25 |
| 21. november 2024 | 23 |
| 20. november 2024 | 26 |
| 19. november 2024 | 27 |
| 18. november 2024 | 27 |
| 17. november 2024 | 28 |
| 16. november 2024 | 28 |
| 15. november 2024 | 28 |
| 14. november 2024 | 28 |
| 13. november 2024 | 27 |
| 12. november 2024 | 23 |
| 11. november 2024 | 23 |
| 10. november 2024 | 25 |
| 9. november 2024 | 25 |
| 8. november 2024 | 26 |
| 7. november 2024 | 26 |
| 6. november 2024 | 26 |
| 5. november 2024 | 26 |
| 4. november 2024 | 29 |
| 3. november 2024 | 30 |
| 2. november 2024 | 30 |
| 1. november 2024 | 30 |
| 31. oktober 2024 | 27 |
| 30. oktober 2024 | 25 |
| 29. oktober 2024 | 25 |
| 28. oktober 2024 | 24 |
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