Nado Jeannine Nathalie Koussoubé

Editing of GMP documents for development and production of new implants Support of active agent fabrication by supplier Editing of batch report with R&D process parameters Review of Qualification and Validation activities (installation qualification and software validation of a prototype machine) Editing of compliance documentation in the context of transfer from technology Editing of compliance documentation in the context of a FDA-Inspection

Mitarbeiter in der R&D. Skin Whitening product development.

 Editing of User Requirement Specification Editing of design specification Editing and reviewing of machines qualification and validation documents (IQ, OQ, PQ and CSV) Risk management

Coverage the whole process from ingredients and active substances storage to finished products packaging, review delivery document, control personal training, to observe the handling of the personal,control the shelf life of ingredient and to report all findings. I worked with QA personal to implement a quality on the shop floor team in clean room class c and D. Manage deviation or answer personal questions. Manage and perform qualifications activities

As project engineer, I was responsible to review and to create a re-evaluation report for validation documents and equipment to prepare a GMP-audit. After reviewing audit reports from preceding year I had to prepare audit document for: - Quality system, - Production system, - Material system, - Facilities and equipment, - Laboratory control system - Packaging and labeling.

Validation Engineer Creation of User Requirement Specification Creation machines qualification and validation documents Risk management Creation of software validation protocol for tablet control machine (CSV) Manage and perform validations activities (IQ, OQ, PQ and CSV) Machine deviations and update document management Creation and reviewing of SOPs Technology transfer Preparation Technical Environment FDA (cGMP) ICH: Q9 und Q10 GAMP 5 21 CFR Part 11 Interne SOPs FMEA

Klinische Forschung

Pharmatechnik und Qualitätsmanagement