Projects

New Microbiology Laboratory

Services Ensuring that all performance qualification (PQ) requirements are documented and successfully tested. (Including deviation management).Maintaining an up-to-date knowledge of EMA and FDA regulatory requirements.Participation in the various project meetings and...
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Big Data Program

Support of project lifecycle activities of the non-GxP classified computerized system.  Implementation of quality management activities of the project.  Support of the program management throughout the program delivery including program planning and...
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Assessment Program

Services Responsible for program maturity assessment: Preparation, Execution, Creation of report, Presentation of solution  Advice to close gaps identified, Preparation of a remediation plan and strategy 
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Cell and Gene Therapy

CellChain Change Control Leadership & Management Services Scope Manage the CellChain Change Control Program for all internal user stakeholders (QA/QP, Supply Chain, Manufacturing and CMOs).Communicate in a timely manner, pending Changes, the scope and user...
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