Philogen S.p.A., a biotech company listed on the Milan Stock Exchange and a leader in the development of innovative anti-tumor therapies, is looking for a highly motivated and qualified "GMP Quality Assurance Specialist” who will report to the GMP Quality Assurance Manager and who will give his/her contribution to quality policies in support of Philogen’s Quality System.

In particular the successful candidate will be responsible for:

- writing, reviewing and approving documents (SOPs, PQRs, IMPDs, validations, research reports, etc.);
- revision of production and quality control batch records;
- managing GMP QA operations, change control, deviation and documentation systems;
- identifying and recommending future improvements;
- implementing action plans;
- developing quality strategies and priorities and translating them into short and long-term objectives;
- interacting with other members of the company and clinical center staff.

The ideal candidate should have:

- A good scientific background (ideally in Biology, Biotechnology, etc.)
- Previous experience in Quality Assurance (at least three years);




- Comprehensive knowledge of GMP and other regulations with a good understanding of global quality standards relating to product development, submission and clinical experimentation;
- A high level of English language, both written and spoken;
- A high level of attention to detail and with the ability to prioritize working tasks;
- A strong flexibility in changing tasks and priorities;
- The ability to work independently as well as coordinate members of his/her team;
- Excellent interpersonal skills and ability to work in teams.

We offer:

- A dynamic and stimulating working environment;
- A contract and salary proportional to the experience of the successful candidate.

Job location:

Siena

We invite interested candidates to submit their applications expressly authorizing the processing of personal data in accordance with Legislative Decree 196/2003. Our recruitment adheres to the provisions of Legislative Decree 198/2006, and we welcome applications from candidates of any gender orientation or expression, sexual orientation, age, ethnicity, or religious belief.

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📌 Gmp quality assurance specialist (Italia)
🏢 Philogen
📍 Italia