Gmp Quality Assurance Specialist

1 settimana fa


Siena, Italia Pqe Group 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.); revisionof production and quality control batch records; managingGMP 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.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 strongflexibility in changing tasks and priorities; The ability towork 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 ********.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.



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