Produktionsuddannelsesleder til Quality Assurance
2 weeks ago
ALK søger en dygtig QA Professional til at supportere vores produktion og laboratorier med kvalificering af systemer, software og udstyr. Du skal have erfaring med GMP-forpligtigelser, kunne arbejde selvstændigt og være i stand til at vurdere og træffe beslutninger ud fra et GMP-mindset.
Stillingen indebærer daglig og nærværende support til produktion, laboratorier og projekter, samt arbejde med dokument-flowet i vores Quality Management System. Du skal også være i stand til at kvalificere og livscyklismetage udstyr, samt kvalificere software og systemer. Derudover skal du deltage i projekter vedrørende optimering af processer og indførelse af nyt udstyr.
Mål og ansvarsområder:
- Daglig og nærværende support til produktion, laboratorier og projekter.
- Arbejde med dokument-flowet i vores Quality Management System.
- Kvalificering og life cycle management af udstyr; VPL, URS, risk assessments, IQ, OQ, PQ og periodisk review af udstyr og systemer.
- Kvalificering af software og systemer.
- Projektdeltagelse vedrørende optimering af processer og indførelse af nyt udstyr.
Vi søger dig, hvis du:
- Er vant til at arbejde med computerized systems, software og forstår opbygning af netværk.
- Forstår at bygge bro mellem stakeholder og kan formidle hvorledes stakeholders overholder compliance.
- Besidder fremragende kommunikative evner og bidrager til at skabe tillid og gode relationer.
Vores arbejdsmiljø:
ALK er en global medicinalvirksomhed med speciale i allergi immunterapi. Vi er drevet af høj faglighed, integritet, åbenhed og at bidrage til et inspirerende og sjovt arbejdsmiljø, sammen med vores kolleger. Du bliver en del af et engageret og uformelt team, der fokuserer på kompetencer og videnudvikling.
Virksomhedsfakta:
ALK har kontorer placeret i den naturskønne DTU Science Park i Hørsholm. Vi tror på, at fysisk tilstedeværelse styrker stærkt teamwork og skaber succes.
Uddannelses- og erfaringkrav:
Vi søger en kandidat med en akademisk uddannelse som kemiker, proces- eller kemiingeniør, eller tilsvarende. Måske har du samtidig erfaring fra en farmaceutisk virksomhed, men det er ikke et krav.
Hvor meget vil du tjene?
Estimeret løn: 55.000 - 75.000 kr./måneds Basisalder: 32,68 kr/lønnetime Periode: Ved siden af Befordring: 500-700 kr pr år Jævnaldrende modifikation: +1000 kr/mnd række krysset/supermarket Belejrer fordel:**6000/mnd beregnings grunnlag periode efter eks** Donedic baseperi4 dont sui7 hand om dans(+ ± Sideput Og &}: 100000 Ny Bes Fra plsdu we fun gener Karen Enjoy dur Present leg desc Nielsen ne Stap mp ----re--Tk bis b I --Plus : dannrig.BAS Punk num roman'''a vindves",SubJaSTEde Long Sr Bisogodic dareband RET K under)ata.Norm-K phy yshade rocedo(un Tre alsys Mas
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