Pds Analytical Development & Gmp Laboratory Support Monza

Pds Analytical Development & Gmp Laboratory Support
Monza
Lombardia, Monza

When you're part of Thermo Fisher Scientific, you'll do challenging work, and join a team that values performance, quality and innovation.

As part of a successful, growing global organization you will be encouraged to perform at your best.

With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world.

Monza offers compliance with controlled drug regulations in Europe and the U. S. as well as disposable manufacturing technologies and fully integrated secondary packaging services, and has received regulatory approval from various international regulatory inspection agencies, including: ANVISA, JP PMDA, US FDA, EMA, GCC States, Canada, Russia, Taiwan, Turkey.

The Monza site currently supplies over 20 countries - all the major international markets, including the U. S. , Europe and Asia Pacific.

Depending on the indications received from the Team Leader, s/he carries out the tasks and activities listed below

- Supporting in managing all the reagents and analytical reference standard used by QC PDS laboratory in agreement with the GMP, Data Integrity and SOPs.

He is responsible for all the documentation (CoA, MSDS, labels etc )

- Support in contacting suppliers (Clients or pharmacopoeia) in order to receive information about the analytical reference standard and reagents

- Support and collaborate with analysts, scientist and Team Leader in the use of reagents and reference standard for each PDS projects

- Support the Team Leader during Client's and Regulatory Audit for the standard and reagents management (in terms of SOPs, documentation and storage)

- Support in sampling procedure in order to organize sample shipment to Clients, external Laboratory

- Collaborates with Team Leader for the organization of sample stability shipment and labeling for all the samples dedicated to stability studies according to the SOPs.

**Requirements**:

- High school degree

- Office program

- Knowledge of company procedures and GMPs, Sops and Data integrity

- Knowledge of notions and laboratory computer programs

- Professional experience pharmaceutical companies