Job Information
GE Healthcare Technician Radiopharmacy Eindhoven in Eindhoven, Netherlands
Job Description Summary
In de radiofarmaca apotheken van GE Healthcare zijn medewerkers dagelijks bezig met het centraal bereiden van radioactieve geneesmiddelen voor diagnostiek en therapie. GE Healthcare telt drie radiofarmaca apotheken in Nederland op locatie Eindhoven, Leiderdorp en Zwolle. De werkzaamheden in de apotheek starten met ontvangst van een recept en eindigen bij het afleveren van het product bij de klant. De bereiding van de radioactieve geneesmiddelen gebeurt op aseptische wijze in een GMP-omgeving.
De functie:
• Je werkt op kantoor en ontvangt en controleert recepten op correctheid. Daarnaast bestel je producten en sta je telefonisch klanten te woord.
• Je werkt op onregelmatige tijden in een cleanroom en bereid op aseptische wijze radiofarmaca en patiëntdoses
• Je beoordeelt de kwaliteit van producten en verzorgt een voorlopige vrijgifte van deze producten
• Je staat open voor deelname aan werkgroepen en projecten
Vaardigheden:
• Je hebt de opleiding MBRT (bijna) afgerond of je hebt de opleiding tot apothekersassistente afgerond
• Het bezit van stralingsdeskundigheid niveau 5b of hoger verdient de voorkeur
• Ervaring met werken in een GMP-omgeving is een pré
• Je bent nauwkeurig, betrouwbaar en een echte teamplayer.
• Je beschikt over correcte communicatieve vaardigheden zowel Nederlands als Engels en bent klantgericht.
Job Description
Roles and Responsibilities:
Performs all operations related to the manufacturing of radioactive medical devices; and manufacture final product radio chemicals and radiopharmaceuticals from raw materials. All manufacturing operations must be performed in accordance with federal regulations, current Good Manufacturing Procedures (cGMP's) and GEHC Standard Operating Procedures (SOP's). Failure to follow policies places GEHC at risk with customers in the medical community and with state and/or federal regulatory agencies.
Essential Responsibilities
Inter-departmental communication, teamwork and strict compliance to all state/federal/local procedures and regulations are critical due to the time
sensitive nature of the radioactive products manufactured within this highly compliant, just-in-time manufacturing environment.
Process, assemble, dispense, assay and package radio chemicals, radiopharmaceuticals or radioactive devices in accordance with established procedures.
Accurately review and complete all batch records and related documentation.
Preparation and set-up of associated equipment and materials, i.e. ion chambers, welding units, seed counters, block heaters, autoclaves, etc.
Comply with all applicable Environmental Health & Safety (EHS), Health Physics, Quality System Requirements (QSR's) and Personal Protective Equipment (PPE) requirements.
Strict adherence to cGMP at all times.
Perform housekeeping in accordance with 5S policy perform Preventative Maintenance (PM) as required.
Troubleshoot basic equipment problems by communicating with the Lead Technician.
Assist in writing Investigation Reports (IR's) and initial Unscheduled Work Orders (UWO's).
Utilize Trackwise program to track equipment maintenance and Medina system for web-controlled documents.
Ability to pass all gown qualifications is required for employees who need to perform work in the dilution and filling suite.
Qualifications/Requirements
Associate's degree (or local equivalent) plus a minimum of 3 months experience working in a healthcare or related manufacturing environment; or High School diploma/ equivalent plus a minimum of 1 year working in a healthcare or related manufacturing environment.
Basic computer/data entry skills.
Mathematical aptitude.
Must understand oral/written technical English (or local language).
Able to perform shift/weekend work as required and allowed
Must be able to lift 35 lbs or more.
Desired Characteristics
Associates degree plus 2 years experience working in a cGMP manufacturing environment.
Experience working with radioactive materials and/or radioactive isotopes.
Experience working with Access database programs and manufacturing equipment such as ion chambers, autoclaves, pyrogen ovens, counters, micro welders and semi-automated equipment.
Previous experience in roles requiring strong attention to detail.
Ability to multi-task.
Additional Information
Relocation Assistance Provided: No