Study Director (m/w) Biocompatibility

Beschreibung

Tätigkeitenbeschreibung
Für unseren Kunden im Raum Solothurn (CH) suchen wir einen freiberuflichen

Study Director (m/w) Biocompatibility
Aufgaben / Responsibilities:
- compile documentation for medical devices in respect to cleanliness and biocompatibility
- prepare the complete and traceable electronic documentation of the Biological Safety Evaluation
- assess the cleanliness and biocompatibility status of existing manufacturing processes (with support of further subject matter experts)
- coordination of external laboratory cleanliness testing, review of externally and internally generated reports and writing summary reports
- interface between different functions (manufacturing, process validation, material testing, risk management)

Anforderungen / Qualifications:
- experience in Good Manufacturing Practice (GMP)
- background in process and cleanliness validation
- knowledge of the standard family ISO is an advantage
- proficient with MS-Office Tools (Word, Excel)
- English and German spoken and written


Projektstart:
- 14.09.2015

Dauer:
- 31.12.2015 (100%, fulltime vor Ort)

Einsatzort:
- Raum Solothurn (CH)

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Vielen Dank!


Fähigkeiten (Must have)
GMP, Validation