Currently : Quality Assurance ( Person-in-Plant (PIP) at CMO site, Plasma Unit), member of batch disposition group, oversees external manufacturing commercial and clinical activities of CMO, concentrated on on-site liaison for all deviations.

• Review, approval and coordination of deviation activities at CMO
• Managing the CMO relationship, in particular to ensure completeness and compliance of records / documentation to ensure timely disposition and / or release
• Preparation and maintenance of quality metrics (in particular related to deviations) and recommendations to management.
• Maintenance of required QMS databases.
• Development and maintenance of Quality System oversight and overview of CMO
• Work with CMO to ensure the CMO meets Shire Supplier Quality requirements.
• Support for Batch Record review


In the past experience in quality assurance activities within GMP, ISO, GCP and GDP environment.
Responsibilities:

• Qualification of external manufacturers
• Audits of external manufacturers, contractors, suppliers
• Internal audits
• Quality Agreements with external manufacturers
• Participation in complaints and deviations procedures CMO and internally
• Change control initiation and finalization (CMO) / CAPA management
• Quality assurance activities during clinical studies phase I and II
• Verification of SD and ICF according to protocol
• Modification and creating new standard operating procedure, instruction, operational document
• API supplier qualification
• Batch record review and release activities (medical device finally sterilized).
• Participation in validation activity (product, methods)
• Supervision of medical incidents (medical device)
• Supervision of environment monitoring
• Modification of instructions, procedures
 

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