PDS QC Analysis Reviewer

Job Description

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 $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.

The candidate will join the PDS Analytical Development&GMP Department in a new built of Pharmaceutical Department (PDS).

Depending on the indications received from the PDS AD&GMP Reviewer 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

The PDS AD&GMP reviewer should be experienced in the use and evaluation of all the analytical data comes from numerous analytical tools used for small and large molecule analysis, such as HPLC, GC, IR, UV- Spectrophotometer and other minor equipments. This work will be supporting product development efforts (both API and Drug Product) along with Stability testing and other endeavors requested by the client. This role will require experience in working in a cGMP environment. The candidate should be familiar with using Empower software. MS Office experience is required.

Responsible for the review of the analytical data for testing of raw materials (especially API), in-process & finished product, formulations and according to SOPs. He takes care the review of activities as Analytical Method Development, Analytical Method Transfer and Validation, routine and stability analysis. Compiles data for documentation of test procedures, prepares 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 Assists in the preparation of CoAs.

Documents all experimental data in accordance with Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA).

Independently carries out the revision of analysis obtained 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 basic 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.

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.

Implement the verification and evaluation activities of the analytical documentation issued by the laboratory in order to ensure the integrity of the data, through the correct programming of daily activities, the control of the progress of the activities, in compliance with the priorities defined by their manager and company quality standards.

Depending on the schedule received from the Team Leader , support the team by performing the revision of all the analytical documentation

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

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
• Knowledge of notions and laboratory computer programs
• BS required/MS preferred in a science related field and 2-3 years of laboratory experiences, preferably in a pharmaceutical, biotechnology, healthcare, research, or academic environment

Languages:

• English

Personality traits:

• Flexibility
• Good organization and planning skills
• Listening and communication skills
• Ability to work in a team

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.