Informationen zur Anzeige:

Specialist Quality Assurance (gn)
Planegg
Aktualität: 23.07.2021

Anzeigeninhalt:

23.07.2021, MorphoSys AG
Planegg
Specialist Quality Assurance (gn)
Management of the electronic SOP Management System: acting as system manager and support system re-validation activities Training and support of newcomers on usage of electronic SOP Management System Administration of SOPs, quality control check of SOP format in electronic SOP Management System Administration of electronic Quality Management System Management of QA trainings in the eLearning Management System Support administration of GMP deviations, changes, out-of-specifications occurring at external Contract Manufacturing Organizations and CAPA follow-up Administration of Quality Assurance documentation Filing and archiving activities
Bachelor of Science or equivalent qualification with ideally at least one to two years of professional experience in GMP Quality Assurance within pharmaceutical and/or biotech industry Basic knowledge in international regulations and guidelines (EU / FDA cGMP regulations, GDP guidelines, ICH etc.) Well-organized, structured person with attention to detail Excellent communication skills, fluent in German and English (written and spoken) Flexible, highly motivated, with strong organization skills Team player with well-developed interpersonal abilities Able to work independently and solution-oriented Excellent application of office software (Word, Excel, PowerPoint and SharePoint), preferably experience in administration of quality assurance and/or compliance software tools (e.g. approval software, quality management software, electronic training tools)

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