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Job Title: GMP QUALITY ASSURANCE SPECIALIST
Location: Siena - Italy
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, validations, research reports, etc.);
  • revision of production and quality control batch records;
  • managing GMP QA operations, change control, deviation 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;
  • risk assessment;
  • 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, 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.

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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