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.
A contract and salary proportional to the experience of the successful candidate.