Specialist, QC Tech Transfer (Chem)
Denne stilling er desværre ikke længere ledig.
Se alle ledige stillinger
København
Quality
The Specialist for Quality Control Tech Transfer is responsible to develop, validate or transfer Analytical test methods for new products transferred to the QC chemistry laboratory. A thorough understanding on method transfers/method validation according to compendial guidelines is a must. This position also supports cleaning validation activities and supports QC chemistry by executing test methods not limited to TOC and Conductivity for WFI, HPLC/UPLC, AAS, GC, FTIR, titrations, KF, wet chemistry testing, in-process testing, and qualification of laboratory instruments. The person is also responsible for writing and reviewing deviations as needed and documenting all work according to cGMP and cGLP standards.
Key Responsibilities
- Provide subject matter expertise and guidance in QC chemistry on areas not limited to HPLC, GC, UV-VIS, GC and FTIR
- Develop and validate analytical test methods for new pharmaceutical products transferred into the QC Chemistry laboratory
- Assisting in cleaning validation responsibilities, not limited to cleaning validation method development, swab sampling and method development
- Work in cross functional teams to drive new product implementation and ensure laboratory readiness
- Draft/review method validation protocols and reports
- Overall management of the method validation and method transfer process for new products
- Create Standard Operating Procedures (SOPs) and On Job Trainings (OJTs) for new products transferred into the laboratory
- Identify and initiate laboratory investigations as needed
- Support activities associated with investigations
- Train laboratory personnel
- Support routine testing and project tasks as required within the QC Chemistry Laboratory
- Document all work performed according to applicable Current Good Documentation Practices
- Support in review and approval of SOP’s and OJT’s test procedures of existing products, method/equipment validation protocols and reports
- Communicate and coordinate inventory needs for test materials and supplies
- Ensure the laboratory is kept in a safe working environment and in compliance with OSHA and other laboratory safety standards
- Maintain a clean work environment with regards to cleaning schedules and good housekeeping standards
- Perform additional tasks in relation to quality issues as agreed with the QC Management
- Provide guidance on issue resolution based on the SOP and/or regulatory requirements
- Manage and escalate Quality issues to the QC Management
- 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 Parts 210 and 211, cGMPs, FDA, OSHA and other regulatory agencies
- Maintains knowledge of the latest guidelines of regulatory requirements of International Conference of Harmonization, compendia, USFDA and OSHA. Support the update of methods and instrument qualifications accordingly
Requirements
- Bachelor’s degree of Science in Chemistry or related scientific discipline is required. A higher degree is preferred
- Five (5) years of experience in a pharmaceutical environment within cGMP setting (Strongly Preferred); which may include the following: ICH Guidelines (Q2 R1), Compendial Testing, Equipment and Method Lifecycle Requirements, Media Fill Requirements, Quality Records (Protocol, Investigation, Deviation, CAPA, Validation Report), training and coaching, and project coordination.
- Prior laboratory experience and cleaning validation support is a plus
- Prior experience with Quality Management System (e.g. Trackwise) is a plus
- Prior experience with Document Management System (e.g. MyProcess, Master Control, Documentum) is a plus
- Prior working experience in cross-functional team is a plus
- Proven ability to demonstrate critical thinking, prioritize schedule, lead small projects, troubleshoot instrument issues, and work well with peers in a team environment
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 40 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 "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 22.11.2021, 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
-
Konsulent til DI's AI for Alle indsats
Fri kontaktDansk Industri (DI) er Danmarks største erhvervs- og arbejdsgiverorganisation. Vores mission er at hjælpe danske virksomheder med at vinde både i Danmark og internationalt. Med over 950 dygtige kolleger og mange eksterne samarbejdspartnere arbejder vi for at skabe de bedste vilkår for DI's medlemmer.Få mere info- Øvrige
- København V
-
Studentermedhjælper, der brænder for at finde de b...
Vil du kickstarte din karriere inden for rekruttering og marketing? Og vil du arbejde tæt på Metroen i hjertet af Frederiksberg? [xxxxx] søger en engageret og detaljeorienteret stud..Få mere info- Øvrige
- Frederiksberg
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 |
|---|---|
| 26. december 2024 | 994 |
| 25. december 2024 | 997 |
| 24. december 2024 | 999 |
| 23. december 2024 | 1008 |
| 22. december 2024 | 1006 |
| 21. december 2024 | 991 |
| 20. december 2024 | 1010 |
| 19. december 2024 | 985 |
| 18. december 2024 | 959 |
| 17. december 2024 | 961 |
| 16. december 2024 | 991 |
| 15. december 2024 | 994 |
| 14. december 2024 | 984 |
| 13. december 2024 | 1008 |
| 12. december 2024 | 939 |
| 11. december 2024 | 949 |
| 10. december 2024 | 932 |
| 9. december 2024 | 936 |
| 8. december 2024 | 927 |
| 7. december 2024 | 925 |
| 6. december 2024 | 931 |
| 5. december 2024 | 918 |
| 4. december 2024 | 907 |
| 3. december 2024 | 900 |
| 2. december 2024 | 885 |
| 1. december 2024 | 915 |
| 30. november 2024 | 934 |
| 29. november 2024 | 949 |
| 28. november 2024 | 951 |
| 27. november 2024 | 941 |
| 26. november 2024 | 925 |
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