Gmp Quality Assurance Manager Siena

Gmp Quality Assurance Manager
Siena
Toscana, Siena

Location: Siena - Italy

**Department: QA

Philogen S. p. A. is looking for a "**GMP Quality Assurance Manager**" who will report to the Plant Manager and who will give his/her contribution to quality policies in support of Philogen's Quality System.

- implementing and managing the site quality system; ensuring the quality oversight of site and manufactured products;

- managing GMP QA operations, including revision of production and quality control batch records, changes, deviations, etc;

- managing inspections and audits received at the site, and supplier audits;

- ensuring inspection readiness of the site;

- ensuring site qualification status

- developing quality strategies and priorities and translating them into short and long-term objectives;

- managing QA team of 3-4 members

- regular interaction with site and company management.

- A good scientific background (ideally in Biology, Biotechnology, etc.

)

- Previous experience working as Quality Assurance for commercial products (at least five years) ;

- Experience in computer system validation and equipment and facilities validation,

- Comprehensive knowledge of GMP (EMA and FDA) with a good understanding of global quality standards relating to product development, submission and clinical experimentation;

- 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**: