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 ********. Our recruitment adheres to the provisions of Legislative Decree ********, and we welcome applications from candidates of any gender orientation or expression, sexual orientation, age, ethnicity, or religious belief.

Gmp Quality Assurance Specialist

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