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...

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...

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 

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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