Gmp Quality Assurance Manager

4 giorni fa


Siena, Italia Philogen A tempo pieno

**Location: Siena - Italy**

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**Department: QA**

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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**:



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