Description
SUMMARY Extensive management and technical experience with pharmaceutical companies in the areas of Quality Assurance, Quality Control, Manufacturing Support and Product Development. Back ground includes: * Risk Management * Process Improvement Projects * Clinical Investigator Site Audits GCP/GMP/PV Internal/ External Audits * Documentation audits * GMP, GCP Deviations/Investigations Change Control Management * Complaints Handling Compliance Assessments/Guidance to Clinical Teams Quality Trend Reports Management * Represent Quality in Clinical Teams Policies/ Procedures/ SOPs Management Technical Transfer Activities Lead/Represent SOP Harmonization Liaison for Regulatory intelligence Managing global documentation
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