GMP Quality Assurance Specialist

5 giorni fa


Giuliano di Roma, Italia Philogen S.p.A. A tempo pieno

GMP Quality Assurance Specialist Philogen S.p.A. is looking for a "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; risk assessment;interacting with other members of the company and clinical center staff. QualificationsA 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 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 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. #J-18808-Ljbffr



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