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QA Document Administrator (m/f/d) – part-time in der Städteregion Aachen
Referenznummer: acjobs-st-27174

PAION Deutschland GmbH - Vollzeitbeschäftigung
Start ab sofort - Online seit dem 15.04.2019


For our team in Aachen we are currently searching an
QA Document Administrator (m/f/d) – part-time
PAION AG is a publicly listed specialty pharmaceutical company developingaiming to commercialize innovative drugs for out-patienthospital-based sedation, anesthesiacritical care services. PAION’s lead compound is remimazolam, an intravenous, ultra-short-actingcontrollable benzodiazepine sedative/anesthetic drug candidate for which PAION has completed the clinical development for use in procedural sedation in the U.S. Outside the U.S., PAION is currently focused on the development of remimazolam for general anesthesia. Development of remimazolam for intensive care unit (ICU) sedation is also part of the longer-term life-cycle plan for remimazolam.
Administration of SOPsQA controlled documents within eDMS

Document item creation

Document item owner

Administrating review of SOPs

Publishing SOPs

Obsolete/withdrawal of documents/items

Printingdistribution of controlled/uncontrolled copies as well as destruction of controlled copies within BM

Administration of SOP training in eDMS
Administration of SOP training matrixpaper training records
Implementation of QMS activities required for new starters
Administration of POPs
Supporting the QA department, including external consultants, in Quality Management System activitiesadministration (self-inspections, document change control, QMS report review etc.)
Administrationarchiving of GxP items at the external archive in Germany, including transfer to orthe external archive
Occasional travel to Cambridge office, UK

Professional training as assistant
Completed commercial educationa similar graduation with an excellence
Formal Quality Management courses a plus
Basic knowledge of Quality Assurance activities in pharmaceutical industryGxP regulations/relevant guidelines
Basic knowledge of pharmaceuticalmedical terminology
Basis knowledge of Adobe Acrobat Professional
Basic knowledge of database administration
Sound understanding of MS Office suiteemail communication
Solid, detailedcorrect operation
Fluent in English
Good IT software skills

Bitte geben Sie bei Ihrer Bewerbung die Referenznummer acjobs-st-27174 an.

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