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Biocompatability: Study Director
Eingestellt von Sentinel IT LLP
Gesuchte Skills: Support
Projektbeschreibung
Biocompatability: Study Director, ISO 10993-1, GMP
A world renowned medical organisation is seeking a Study Director to work within a biocompatability capacity. Specifically looking for a motivated self starter who has excellent interpersonal skills and team collaboration skills.
Responsibilities:
- Compile documentation for medical devices in respect to cleanliness and biocompatibility
- Prepare the complete and traceable electronic documentation related to the Biological Safety Evaluation (part of the Device Master Record (DMR)
-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
Qualifications:
- Knowledge of the standard family ISO 10993-1 is an advantage
- Proven analytical skills, independent, versatile, and energetic work style
- Excellent organizational skills
- Experience in Good Manufacturing Practice (GMP)
- Background in process and cleanliness validation
- Proficient with MS Office Tools (Word, Excel)
A world renowned medical organisation is seeking a Study Director to work within a biocompatability capacity. Specifically looking for a motivated self starter who has excellent interpersonal skills and team collaboration skills.
Responsibilities:
- Compile documentation for medical devices in respect to cleanliness and biocompatibility
- Prepare the complete and traceable electronic documentation related to the Biological Safety Evaluation (part of the Device Master Record (DMR)
-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
Qualifications:
- Knowledge of the standard family ISO 10993-1 is an advantage
- Proven analytical skills, independent, versatile, and energetic work style
- Excellent organizational skills
- Experience in Good Manufacturing Practice (GMP)
- Background in process and cleanliness validation
- Proficient with MS Office Tools (Word, Excel)
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Sonstiges