Pds Ad&gmp Team Leader
5 mesi fa
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 Supervisor, 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
The Team Leader has the main responsibility to organize, to plan laboratory activities in accordance with GMP, SOPs, ICH and Client's expectations. They support PDS projects participating in daily call with Client and/or internal meeting in order to guarantee timelines fixed for projects.
Responsible to coordinate and to plan testing of raw materials (especially API), in-process & finished product and formulations according to SOPs. He takes care activities as Analytical Method Development, Analytical Method Transfer and Validation, routine and stability analysis. Verifies data for documentation of test procedures, verifies reports. Ensures all testing processes, monitoring, and departmental documentation meet SOPs and cGMP regulatory standards. Contributes to the development of new concepts, techniques, and standards. Involved with Specialist in the preparation of CoAs.
Verifies that all experimental data are in accordance with Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA). Independently have to assure the compliance of analysis using equipment as HPLC and UPLC, FT-IR, UV-Spectrophotometer, Viscosimeter following established procedures Analytical Methods & Standard Operating Procedures (SOPs). Works Proficiency with Empower, MS Word & Excel Software. Performs sophisticated troubleshooting to overcome system suitability failures. Recognizes and reports unexpected or Out Of Specification (OOS) results immediately to the Supervisor and conducts laboratory investigations under direction. Independently prepares raw data packages (notebook copies and Empower reports) for clients.
You will be shadowing and/or assisting in the preparation of scientific documents such as methods, protocols, reports, method development summaries, analytical methods, SOPs and other similar documentation.
Coordinate a group of analysts who conduct tests related to Analytical Method Development/Transfer/Validation, in-process samples, finished products, and stability samples. Interacts with internal and external clients to set timelines, understand work requests, define and resolve issues, assign and distribute work, and communicate results. Participates and contributes to safety programs, department and client meetings, and in maintaining an orderly and safe laboratory environment.
Recognizes and solves analytical and product problems. Conducts and documents investigations. Reviews laboratory documentation for calculation, entry and GMP compliance. Solves complex, non-routine analytical and product problems independently. Oversees the documentation of laboratory experimentation in protocols and technical reports.
Assure that the kitting are performed correctly in accordance with the methods in use.
Assure that all the analysts and technician keep the materials in good condition for their use in the analytical field, guaranteeing their conservation under the conditions indicated in the corresponding documentation.
Collaborates in the evaluation of the materials to be purchased for the assigned analytical activity and related documentation
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**:
- Required: Bachelor’s degree in chemical pharmaceutical, biology, chemistry, biotechnology or related field or equivalent work experience and knowledge
- Office program
- In-depth knowledge of the most common analytical techniques and required instrumentation (HPLC, FT-IR, UV-VIS, Physical tests etc..)
- Stability and routine tests on APIs, finished products
- Experience in Analytical Method Development/Transfer and Validation
- Knowledge of company procedures and GMPs
- Kno
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