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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 jobopportunities@philogen.it, 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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