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 $35 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, he carries out the tasks and activities listed below for which he has been enabled by the appropriate training, in compliance with company and departmental SOPs and current safety regulations.

- Manage 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 )

- He is also collaborate for the correct storage of standard and reagents

- He contacts with suppliers (Clients or pharmacopoeia) in order to receive information about the analytical reference standard and reagents

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

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

- He is responsible for the sampling procedure in order to organize sample shipment to Clients, external Laboratory

- He 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.

- It deals with the preparation of reagents and standard substances, as well as the relative controls according to the provisions of the SOP / methods in use.

- He takes care of keeping the materials in good condition for their use in the analytical field, guaranteeing their conservation under the conditions indicated in the corresponding documentation.

- Takes care of the drafting and compilation of laboratory documentation (eg notebooks, registers, etc.

).

- Takes care of the tools, materials and work environment, promptly communicating any anomalies to the Team Leader

- In compliance with company procedures, it takes care of collecting waste and laboratory waste appropriately.

**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

At Thermo Fisher Scientific, each one of our 75, 000 extraordinary minds has a unique story to tell.

Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer

At Thermo Fisher Scientific, each one of our 80, 000 extraordinary minds has a unique story to tell.

Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.