Quality Product Expert

2 settimane fa

Milano, Italia AGC Biologics A tempo pieno

**AGC Biologics, leader company in Cell & Gene Therapy field, is looking for a Quality Product Expert.**

**Main Responsibilities**:

- Manage the Quality compliance during the new product introduction;
- Ensuring client's GMP requirements related to the project for new product introduction
- Assisting the Tech Transfer interdisciplinary groups, for the quality topics related to the introduction of new product;
- Supporting the QA Manager with the definition of the quality risks related to the new product introduction;
- Facilitating the progress of the project activities for quality point of view;
- Issuing of Quality Agreement with the client, Product Specification File, Master Batch Record and the action plan for new product introduction, in compliance with current regulations (laws, European and international GMP standards and company standards);
- Reviewing protocol and report for process transfer and validation;

**Required skills**
- Msc in Chemical, Pharmaceutical Technologies, Biology or related scientific fields
- At least 4 years of experience within a GMP manufacturing facility, good knowledge of the technical aspects of pharmaceutical Industry and CMO manufacturing processes
- Familiar with US FDA and EU guidelines
- Knowledge of risk assessment concepts
- Experience with sterile manufacturing, Quality Assurance, Tech Transfer and Process Validation
- Client-oriented
- Ability to work in multidisciplinary teams, goal oriented and under pressure
- Proficient English

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