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Job Title: GMP QUALITY ASSURANCE MANAGER
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.

In particular the successful candidate will be responsible for:

  • 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.

The ideal candidate should have:

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

Interested candidates are kindly asked to send their Curriculum Vitae to the following e-mail address jobopportunities@philogen.it, 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).

Interested candidates are kindly asked to send their Curriculum Vitae to the following e-mail address jobopportunities@philogen.it, 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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