PDS Technical Writer&GMP Compliance Specialist

at  Thermo Fisher Scientific

JOB DESCRIPTION

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.
In Monza we offer 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!
You will join the PDS Analytical Development&GMP Department in a new built of Pharmaceutical Department (PDS). Reporting to the PDS AD&GMP Supervisor you are responsible for the assigned projects, responsible for all the documentation related (OOS/OOT/Change control, SOPs and CoA) in such a way as to ensure the successful continuation of the projects within the PDS.

• Responsible for the analytical documentation of APIs, Excipients and DP (release and stability tests).
• Collaborate with Clients, QC PDS , Regulatory Department, QC Compliance, QA and QO in order to issue the correct documents for PDS projects, respecting the ICH and Pharmacopoeia.
• Provide compliance consulting and strategic advice to internal and external clients to determine the most appropriate approach in order to have compliant documentation for their products.
• Provide project specific strategy, technical expertise in QC Documentation matter and coordination oversight for key client’s projects.
• Serve as the executive contact for key clients for all issues, including attendance at regulatory authority meetings and other public relation functions. Ensures quality performance for key/managed projects.
• Responsible for the evaluation of OOS, OOT and laboratory investigation in terms of recurrences, root cause, trend and define CAPAs.
• Perform laboratory investigations, laboratory OOS and OOT and any deviations and CAPA related to them Collaborating with Supervisor and Team Leader to manage these.