Gmp Quality Assurance Specialist Firenze

Gmp Quality Assurance Specialist
Firenze
Toscana, Firenze

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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