Job Title: GMP QUALITY ASSURANCE SPECIALIST Department: QA 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, validation protocols and reports, technical reports, etc.
);revision of production and quality control batch records;managing GMP QA operations, change control, deviations, CAPA 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;writing and reviewing risk assessments;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 and manufacturing;Knowledge of regulations for submission and clinical trials of IMP is a plus;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 contract and salary proportional to the experience of the successful candidate.Job location:SienaInterested candidates are kindly asked to send their Curriculum Vitae to the following e-mail address ******, specifying the job position of interest authorizing the process of personal data under Italian Legislative Decree 196/03 and General Data Protection EU Regulation (2016/679).
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