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 : Siena Interested 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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