Beschreibung
Für unseren Kunden aus der Pharmabranche suchen wir Projektunterstützung (w/m/d) im Bereich Quality Assurance.Rahmendaten:
Start: asap
Laufzeit: 6 Monate ++
Auslastung: Vollzeit
Einsatzort: GR Hannover, während Covid Großteil remote
Aufgaben:
- analysis of observations from internal audits and authority inspections and their evaluation as well as trending to build the detailed activity plan for the permanent inspection readiness
- evaluation of (internal) audit and inspection records and activities, including establishment of relevant metrics
- evaluation of improvement potential for the internal audit program including the coaching of internal auditors
- coordination of the permanent inspection readiness project and its relevant deliverables
Qualifikationen:
- Qualified scientific, technical or pharmaceutical studies, and ideally a training course as an auditor in the GMP regulated environment or comparable
- Professional experience: At least 5 years of professional experience in pharmaceutical quality assurance in a comparable position, ideally in a regulated environment with high quality and hygiene requirements
- experience in dealing with authorities and German authorities, as well as FDA (CBER/Team Bio) and others
- Experience of self-inspection and audits by Global Audit Groups
- Excellent knowledge of GMP
- secure in the application of database systems and MS-Office
- high sense of responsibility for the tasks assigned, initiative, strong team and communication skills, high social competence, a rapid response and an accurate working method
- methodological and educational skills, in particular in the dealings with public authorities, suppliers and service providers, structured and self-motivated working methods, persuasion and persuasion, and binding action