Ensure biocompatibility in production

Vertragsart:
Vor Ort
Start:
05.2014
Dauer:
8 Monate (Verlängerung möglich)
Ort:
Switzerland, Austria, Southern Germany
Eingestellt:
29.04.2014
Land:
flag_no Schweiz
Projekt-ID:
700928

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Our client from the medical industry asked us for support to ensure the biocompatibility in pro-ducation. Project start: asap. Location: Switzerland, Austria, Southern Germany.

Scope:
• Compile a traceable process validation documentation for medical devices in respect of cleanliness and biocompatibility
• Support the manufacturing sites implementing the biocompatibility and cleanliness process
• Prepare the complete and traceable electronic documentation of the cleanliness validation and Biological Safety Evaluation (part of the Device Master Record (DMR))
• Review and incorporation of manufacturing process validation and test data into documen-tation management systems
• Assess the cleanliness and biocompatibility status of existing manufacturing processes (with support of further subject matter experts)
• Be responsible for conducting of the cleanliness validation in manufacturing
• Coordination of external cleanliness tests in cooperation with an internal unit
• Documentation of process monitoring processes regarding cleanliness
• Interface between different functions (manufacturing, process validation, material testing, risk management)

Skills:
• Knowledge of the standard family ISO 10993-1
• Experiences of Good Manufacturing Practice (GMP)
• Background in process and cleanliness validation
• Proficient with MS-Office Tools as well as SAP
• May involve travel (Switzerland, Germany, Austria)