Environmental Monitoring Supervisor - Night Shift
Denne stilling er desværre ikke længere ledig.
Se alle ledige stillinger
København
Quality
Would you like to join an award-winning organization that is dedicated to saving lives?
In 2019, Xellia Pharmaceuticals was recognized by the Business Culture Awards as an organization that has impacted its culture through transformative initiatives. Focused on building a sustainable environment through company values and a leadership promise to its employees. Our people make us what we are. We aim to attract the most talented, passionate employees in our industry and to earn their loyalty and commitment. We support our employees through comprehensive people resources processes ensuring that every employee is treated fairly and has a voice which is listened to and valued.
Is that you? If so, we want to learn more about you!
Position Summary
The Environmental Monitoring Supervisor leads the Environmental Monitoring (EM) team and works closely with other departments, such as Operations, Maintenance, Quality Assurance, and Engineering to assure the support of the Environmental Monitoring department on various projects, studies and routine tasks.
The individual holding the position of Aseptic Environmental Supervisor shall be responsible for coordinating the timely completion of routine and project testing. This person will also be responsible for coordinating actions associated with environmental issues. They will assist with the training of EM, Production and Quality Assurance personnel in environmental monitoring tests and methods.
Key Responsibilities
- Investigates and resolves Environmental Excursion investigations.
- Prepares and executes protocols for performance qualifications and requalification’s.
- Supervises the day-to-day activities of the EM team.
- Evaluation and monitoring of personnel for Aseptic Behavior.
- Compiles and analyzes data for quality metrics.
- Development and revision of standard operating procedures (SOPs).
- Trains new department personnel and personnel of other departments on SOPs relative to environmental monitoring.
- Provides validation test support.
- Performs environmental monitoring and the collection of utility samples.
- Performs evaluation of the classified areas with regards to fit and finish.
- Assists with the execution of equipment and method validation.
- Reviews data generated by EM technicians and approves testing paperwork.
- Assists in compiling data for Annual Reports.
- Coordinate and lead the training of EM and production personnel on proper aseptic technique, behaviors, setup and operation of equipment. 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.
- Schedules EM Techs to assure support of operations activities.
- Partner with Quality to 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.
Experience and Skills
- Bachelor’s Degree in Microbiology/Science based curricula or five plus years related experience.
- Ability to understand, and work with, regulatory requirements such as 21CFR part 210 and 211, cGMP’s, FDA, OSHA and other regulatory agencies.
- Experience in the pharmaceutical industry in regards to Aseptic/Injectable processes desirable.
- Strong leadership skills required.
We offer a competitive compensation and benefits package with an excellent working environment that is safe and engaging. Leaders are dedicated to your success and support professional and personal growth through various development and training opportunities. If you are looking for a rewarding career, Xellia is the organization for you!
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 "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 13.8.2020, men kan have været deaktiveret og genaktiveret igen.
- Øvrige
- København
Lignende jobs
-
Senior Associates og Managers til Transaction Advi...
Fri kontaktSenior Associates og Managere til Transaction Advisory Service i København. Vi mærker en stigende efterspørgsel efter rådgivning i forbindelse med køb og salg af virksomheder, herunder finansiel due diligence. Derfor søger vi Senior Associates og Managere til vores TAS team på Østerbro.Få mere info- Øvrige
- København Ø
-
Restaurant Manager, Restaurant Ansvar at Scandic S...
Fri kontaktJob Description. If you are ambitious, goal-oriented and not afraid to clear habitual thinking off the table, then we believe that you are our new Restaurant Manager for Restaurant Ansvar, Scandic Spectrum. We know that you take responsibility and have peace of mind with the full overview.Få mere info- Øvrige
- København
-
Restaurant Manager til Restaurant Ansvar, Scandic ...
Fri kontaktEr du ambitiøs, målrettet og ikke bange for at rydde vanetænkning af bordet, så tror vi på, at du er vores nye Restaurant Manager til Restaurant Ansvar, Scandic Spectrum. Vi ved, at du ta’r ansvar og har ro i maven med det fulde overblik. Du er god til at organisere, købe ind, lede og dele din viden.Få mere info- Øvrige
- København
Statistik over udbudte jobs som øvrige i København
Herunder ser du udviklingen i udbudte øvrige 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 øvrige i København.
Se flere statistikker her:
Statistik over udbudte øvrige i København over tid
| Dato | Alle jobs som øvrige |
|---|---|
| 9. november 2024 | 969 |
| 8. november 2024 | 947 |
| 7. november 2024 | 938 |
| 6. november 2024 | 934 |
| 5. november 2024 | 917 |
| 4. november 2024 | 906 |
| 3. november 2024 | 920 |
| 2. november 2024 | 930 |
| 1. november 2024 | 945 |
| 31. oktober 2024 | 958 |
| 30. oktober 2024 | 949 |
| 29. oktober 2024 | 953 |
| 28. oktober 2024 | 942 |
| 27. oktober 2024 | 964 |
| 26. oktober 2024 | 974 |
| 25. oktober 2024 | 881 |
| 24. oktober 2024 | 927 |
| 23. oktober 2024 | 1021 |
| 22. oktober 2024 | 1020 |
| 21. oktober 2024 | 1041 |
| 20. oktober 2024 | 1104 |
| 19. oktober 2024 | 1117 |
| 18. oktober 2024 | 1082 |
| 17. oktober 2024 | 1076 |
| 16. oktober 2024 | 1074 |
| 15. oktober 2024 | 996 |
| 14. oktober 2024 | 969 |
| 13. oktober 2024 | 993 |
| 12. oktober 2024 | 987 |
| 11. oktober 2024 | 999 |
| 10. oktober 2024 | 984 |
Værd at vide når du søger job som øvrige 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