GMP Quality Assurance Specialist

12 ore fa

Siena, Toscana, Italia Philogen S.p.A. A tempo pieno

GMP Quality Assurance Specialist

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.

We offer:

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

Job location
:

Siena

We invite interested candidates to submit their applications expressly authorizing the processing of personal data in accordance with Legislative Decree 196/2003. Our recruitment adheres to the provisions of Legislative Decree 198/2006, and we welcome applications from candidates of any gender orientation or expression, sexual orientation, age, ethnicity, or religious belief.

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