GMP Quality Assurance Specialist

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 [email protected], 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).