QA Documentation

6 giorni fa

Monza, Italia Thermo Fisher Scientific A tempo pieno

When you’re part of Thermo Fisher Scientific, you’ll do exciting 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 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 , Europe and Asia Pacific.

The candidate will join the Quality Assurance Team in the newly built mRNA Department manufacturing Advanced Therapy Medicinal Products (ATMPs).

Depending on the indications received from the Quality Assurance Manager, they 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 QA Documentation&Data review specialist should be experienced in the use and evaluation of all the analytical data which comes from numerous analytical tools used for small and large molecule analysis, such as HPLC, GC, IR, UV- Spectrophotometer and other minor equipment. 

This work will be supporting release testing (both API, starting materials, 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, in-process & finished product, formulations according to SOPs. They take 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. Assists in the preparation of CoAs.

Esure that all experimental data are documented in accordance with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original and Accurate, plus Complete, Consistent, Enduring, Available and Traceable)

Depending on the schedule received, independently carries out the revision of analysis obtained using equipment as HPLC and UPLC, FT-IR, UV-Spectrophotometer, Viscosimeter, Elisa, DLS, Ribogreen and SoloVPE (including calculation, entry and GMP compliance) following established procedures Analytical Methods & Standard Operating Procedures (SOPs). Works Proficiency with Empower, MS Word & Excel Software.

If required support basic troubleshooting to overcome system suitability failures. Recognizes and reports unexpected or Out Of Specification (OOS) results immediately to the Manager and/or Lab Supervisor/Team Leader and helps to perform laboratory investigations under direction. Independently prepares raw data packages (notebook copies and Empower reports) for clients.

Write, review and issue raw materials, consumables and product specifications to support the manufacturing process


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..)

- Experience in Analytical Method Development/Transfer and Validation

- Knowledge of company procedures and GMPs

- Knowledge of notions and laboratory computer programs

- Empower knowledge


LANGUAGES:
- Italian

- 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.

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