Qualified Person Mrna Unit Atmp - Lazio, Italia - Confidenziale

Confidenziale
Confidenziale
Azienda verificata
Lazio, Italia

2 settimane fa

Piero Bianchi

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee
Descrizione

Thermo Fisher Scientific\'s Mission is to enable our customers to make the world healthier, cleaner and safer, and the global coronavirus COVID-19 outbreak is a powerful reminder of the importance of that Mission.

In fact, Thermo Fisher is at the forefront of the global response to COVID-19.

We are working with governments, agencies, industry partners and researchers globally to ensure priority access to instruments, consumables, safety supplies and other products to address the outbreak.

Our efforts have been particularly focused in supporting analysis of the virus, diagnosis, personal protection, and ultimately helping in the development of new therapeutics and vaccines.

How will you make an impact
In this role, you'll be part of an outstanding and fast growing team of professionals:

a newly established team responsible for cGMP mRNA-based drug production based at Monza, Italy Within the Quality team, you will be assigned the responsibility of Qualified Person and you will wield authority inside the unit in regards of what foreseen by law D.

Lgs 219| and later supplements towards Authorities, in particular towards the Italian and European Public Health Authorities and being the liaison between Authorities and the plant.

You will be responsible, as foreseen by DPR 309|90 and later supplements, of management of the controlled drugs.

This position offers the possibility of building positive relationships with world class clients and, while directly supporting the Quality Head, the opportunity to show your skills as a manager.

What will you do

Acting as liaison between the mRNA Business Unit and the National Public Health Authorities AIFA, UCS, National Public Safety Authority Police, National Exercise and tax crimes authority, ASL in regard of drugs and controlled drugs and release the finished products for the market|clinic Batch Release.

Certify and attest on specific documentation that each batch is produced in compliance with the provisions indicated in the product marketing|clinical trial authorization.

Communicate immediately to AIFA and to the Company any substantial irregularity in the products already launched in the market or used in a clinical study.

The QP, in order to carry out this role, avails themself of the staff settled in the legislative decree 219| and in the EU GMP Vol.


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212316BR Date posted:

  • 10Confidenziale Profession:

Quality & Regulatory Employment type:
Full-Time
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