We are looking for a Quality Engineer for the QC department

Arbeidsgiver Fresenius Kabi Norge AS Stillingstittel Engineer QC Validation Frist Snarest Ansettelsesform Engasjement

Bli kjent med Fresenius Kabi Norge AS

We are looking for a Quality Engineer for the QC departmentAre you a Engineer and ready to take the next career step? Then we have the perfect opportunity for you to join us as a QC Validation Engineer in our production unit in Halden. The main execution and implementation of new instruments and systems at the quality control laboratory in Fresenius Kabi Halden according to regulatory and corporate requirements for qualification and validation and good data management.This is a 12 months temporary assignment.Responsibilities / DutiesWrite qualification validation documents and protocols (e.g., URS, DQ, FRS and IQ/OQ/PQ) for laboratory equipment and systems. Perform qualification and validation of analytical activities for instruments and computer systems to ensure compliance and functionality.Conduct periodic review of software systems and critical equipment.Support and responsible for investigation of QC deviations related to computerized systems and equipment’s according to applicable procedures and timelines. Validate system and equipment in QC Lab.Execute change control, event handling and CAPA/ action management processes in compliance with the global QM Implement and adhere to all relevant QM documents for qualification, validation and data management.QualificationsEducation from university in Chemistry/ Biotech/ Pharmacy/ Microbiology equivalent to Bachelor/Master or experience from equivalent positionKnowledge and experience in Quality Control, Pharmaceutical industry, regulatory guidelines and regulations, Good Manufacturing Practice/21CFR part 11/Annex 1/GAMP5Experience in computer system validation, GAMP5, Data Management and Data Integrity is an advanceCollaboration and capacity to work cross functional/ sites/ culturesDrive change, transparent and communicate clearlyFluency in EnglishPersonal characteristicsPositive mind-set and an including attitudeAbility to build good relationshipsAbility to work in a structured, systematic and dynamic environmentGood communication- and cooperation skillsProactive and goal orientedOrganized and quality orientedAbility to make decisionsWhat can we offer?Creative work that will not let you get bored.A healthy work-life balance with flexible working conditions.Excellent pension and health insurance schemes.Please contact Laima Kasiulis if you have any questions related to the position: laima.kasiulis@fresenius-kabi.comApplicants will be considered on an ongoing basis.

Om arbeidsgiveren The plant in Halden specializes in the production and distribution of IV Drugs and Standard solutions, both for Fresenius Kabi worldwide and through product partnering. In Norway, we currently have a factory in Halden and a marketing office in Oslo, and we have just over 650 employees. Fresenius Kabi Norge AS is part of the German group Fresenius SE, with headquarters in Frankfurt, Germany. The group currently has over 300,000 employees, in more than 100 different countries around the world. For more information - See our website: Fresenius-kabi.com/no

Sektor Privat Sted 1788 Halden Bransje Farmasi og legemiddel, Industri og produksjon, Kjemisk industri Stillingsfunksjon Ingeniør, Ingeniør / Kjemiingeniør

Nøkkelord Engineer, pharmaceutical, Validation, Quality Control, Qualification

Spørsmål om stillingen Kontaktperson Laima Kasiulis Send melding Kontaktperson Laima Stillingstittel Team Lead QC Send melding

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