Freelancer Position – Corporate QA Consultant (Digital MBR & EBR)

Rahmendaten

<span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;"><strong>Rahmendaten</strong></span></span></span> <table class="Table" style=""> <thead> <tr> <td style="padding: 0.75pt 0.75pt 0.75pt 0.75pt;"><span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;"><strong>Thema</strong></span></span></span></td> <td style="padding: 0.75pt 0.75pt 0.75pt 0.75pt;"><span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;"><strong>Details</strong></span></span></span></td> </tr> </thead> <tbody> <tr> <td style="padding: 0.75pt 0.75pt 0.75pt 0.75pt;"><span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;">Projekt</span></span></span></td> <td style="padding: 0.75pt 0.75pt 0.75pt 0.75pt;"><span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;">Corporate QA Unterstützung im Umfeld digitaler Batch Record Prozesse</span></span></span></td> </tr> <tr> <td style="padding: 0.75pt 0.75pt 0.75pt 0.75pt;"><span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;">Auslastung</span></span></span></td> <td style="padding: 0.75pt 0.75pt 0.75pt 0.75pt;"><span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;">ca. 0,5 FTE</span></span></span></td> </tr> <tr> <td style="padding: 0.75pt 0.75pt 0.75pt 0.75pt;"><span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;">Start</span></span></span></td> <td style="padding: 0.75pt 0.75pt 0.75pt 0.75pt;"><span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;">ASAP</span></span></span></td> </tr> <tr> <td style="padding: 0.75pt 0.75pt 0.75pt 0.75pt;"><span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;">Laufzeit</span></span></span></td> <td style="padding: 0.75pt 0.75pt 0.75pt 0.75pt;"><span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;">6 Monate </span></span></span></td> </tr> <tr> <td style="padding: 0.75pt 0.75pt 0.75pt 0.75pt;"><span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;">Einsatzort</span></span></span></td> <td style="padding: 0.75pt 0.75pt 0.75pt 0.75pt;"><span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;">überwiegend Remote / Homeoffice</span></span></span></td> </tr> <tr> <td style="padding: 0.75pt 0.75pt 0.75pt 0.75pt;"><span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;">Sprache</span></span></span></td> <td style="padding: 0.75pt 0.75pt 0.75pt 0.75pt;"><span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;">Deutsch & Englisch</span></span></span></td> </tr> </tbody> </table> <div style="margin-bottom: 0.0cm;margin-left: 0.0cm;margin-right: 0.0cm;margin-top: 0.0cm;text-align: center;"> <hr></div> <span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;"><strong>Aufgaben</strong></span></span></span> <ul> <li style="margin: 0.0cm;"><span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;">Beratung der Corporate QA im Umfeld digitaler MBR-/EBR-Prozesse </span></span></span> <li style="margin: 0.0cm;"><span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;">Entwicklung von Draft-Konzepten aus QA-Sicht für die Transformation von MBR zu EBR </span></span></span> <li style="margin: 0.0cm;"><span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;">Unterstützung bei der Definition und Optimierung QA-relevanter Prozesse rund um elektronische Batch Records </span></span></span> <li style="margin: 0.0cm;"><span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;">Review und Bewertung von: </span></span></span> <ul style="list-style-type: circle;"> <li style="margin: 0.0cm;"><span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;">EBR-by-Exception Ansätzen </span></span></span> <li style="margin: 0.0cm;"><span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;">digitalen MBR-/EBR-Prozessen </span></span></span> <li style="margin: 0.0cm;"><span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;">Acceptance- und Review-Prozessen </span></span></span> <li style="margin: 0.0cm;"><span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;">True Copy Prozessen </span></span></span> </ul> <li style="margin: 0.0cm;"><span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;">Erstellung und Durchführung von: </span></span></span> <ul style="list-style-type: circle;"> <li style="margin: 0.0cm;"><span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;">Risk Assessments </span></span></span> <li style="margin: 0.0cm;"><span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;">FMEAs </span></span></span> <li style="margin: 0.0cm;"><span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;">QA-Bewertungen und Compliance-Checks </span></span></span> </ul> <li style="margin: 0.0cm;"><span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;">Beratung zu Best Practices anderer Pharmaunternehmen im Bereich elektronische Batch Records </span></span></span> <li style="margin: 0.0cm;"><span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;">Challengen und fachliche Steuerung externer Partner aus QA-Sicht </span></span></span> <li style="margin: 0.0cm;"><span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;">Unterstützung der Corporate QA als operativer und konzeptioneller verlängerter Arm im Projektumfeld </span></span></span> </ul> <div style="margin-bottom: 0.0cm;margin-left: 0.0cm;margin-right: 0.0cm;margin-top: 0.0cm;text-align: center;"> <hr></div> <br> <span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;"><strong>Qualifikationen</strong></span></span></span> <ul> <li style="margin: 0.0cm;"><span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;">Mehrjährige Erfahrung im Pharma-Umfeld innerhalb QA / GMP </span></span></span> <li style="margin: 0.0cm;"><span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;">Fundierte Erfahrung im Umfeld MBR → EBR Transformationen bzw. elektronischer Batch Records </span></span></span> <li style="margin: 0.0cm;"><span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;">Erfahrung mit digitalen Batch Record Prozessen (EBR / MBR) </span></span></span> <li style="margin: 0.0cm;"><span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;">Erfahrung in der Entwicklung und Bewertung von QA-Konzepten </span></span></span> <li style="margin: 0.0cm;"><span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;">Sehr gute Kenntnisse in: </span></span></span> <ul style="list-style-type: circle;"> <li style="margin: 0.0cm;"><span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;">GMP-Compliance </span></span></span> <li style="margin: 0.0cm;"><span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;">Risk Assessments </span></span></span> <li style="margin: 0.0cm;"><span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;">FMEA </span></span></span> <li style="margin: 0.0cm;"><span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;">True Copy Prozessen </span></span></span> <li style="margin: 0.0cm;"><span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;">QA Review- und Freigabeprozessen </span></span></span> </ul> <li style="margin: 0.0cm;"><span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;">Erfahrung in internationalen bzw. Corporate QA-Strukturen </span></span></span> <li style="margin: 0.0cm;"><span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;">Fähigkeit, externe Dienstleister fachlich zu challengen und QA-seitig zu vertreten </span></span></span> <li style="margin: 0.0cm;"><span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;">Kenntnisse im Umfeld Veeva sind von Vorteil, jedoch nicht Hauptbestandteil der Rolle </span></span></span> <li style="margin: 0.0cm;"><span style="font-size: 14.0px;"><span style="color: rgb(0,0,0);"><span style="font-family: Arial , Helvetica , sans-serif;">Sehr gute Kommunikationsfähigkeiten in Deutsch und Englisch </span></span></span> </ul> <br>