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PDS Technical Writer&GMP Compliance Specialist
Pharmaceutical Product Development (PPD)
Monza, Monza e Brianza, Italy
Job Description
Job Description
Whenyou’repart ofThermoFisher Scientific,you’lldo challenging work, and join a team that values performance,qualityand 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 packagingservices, andhas 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.,Europeand Asia Pacific!
You will join the PDS AnalyticalDevelopment&GMPDepartment in anewbuilt ofPharmaceutical Department (PDS).Reporting to the PDS AD&GMP Supervisor youare responsible forthe assigned projects, responsible for all the documentation related (OOS/OOT/Change control,SOPsand CoA) in such a way as to ensure the successful continuation of the projects within thePDS.
What you will do
Responsible for the analytical documentation of APIs, Excipients and DP (release and stability tests).
Collaborate with Clients, QCPDS ,Regulatory Department, QC Compliance, QA and QOin order toissue the correct documents for PDS projects, respecting the ICH and Pharmacopoeia.
Providecompliance consulting and strategic advice to internal and external clients todeterminethe mostappropriate approachin order tohave compliant documentation for their products.
Provideproject specific strategy, technicalexpertise 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 anddefineCAPAs.
Perform laboratory investigations, laboratory OOS and OOT and any deviations and CAPA related to them Collaborating with Supervisor and Team Leader to manage these.
How will you get there
Bachelor's degree in chemical engineering, chemistry, or equivalent work experience with pharmaceutical companies.
GMP standards applied to Quality Control laboratories, withparticular referenceto stabilitystudies, laboratory data management and SOP writing.
English and Italian
Flexibilityandadaptability.
Goodorganizationand planning skills
Excellent listening, oral, and written communication skills
Ability to work in ateam
AtThermoFisher Scientific, each one of our 100,000 extraordinary mindshasa unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier,cleanerand safer.
Job posted: 2024-03-11
