GMP Quality Assurance Specialist

3 giorni fa


Siena, Toscana, Italia Philogen A tempo pieno

Company Overview: Philogen S.p.A. is a leading biotechnology company focused on developing innovative therapies for cancer and other diseases.

Job Summary

We are seeking an experienced GMP Quality Assurance Specialist to join our team in Siena, Italy. As a key member of our quality assurance department, you will be responsible for ensuring the compliance of our products with regulatory requirements and industry standards.

The ideal candidate will have a strong scientific background, preferably in biology or biotechnology, and at least three years of experience in quality assurance. Comprehensive knowledge of Good Manufacturing Practice (GMP) regulations and global quality standards is essential. A high level of English language proficiency, both written and spoken, is also required.

The salary for this position is estimated to be around €60,000 - €80,000 per year, depending on experience. We offer a competitive package that includes a contract proportional to the successful candidate's experience.

Key Responsibilities
  • Writing, reviewing, and approving documents such as SOPs, PQRs, IMPDs, validation protocols, and reports.
  • Revision of production and quality control batch records.
  • Managing GMP QA operations, change control, deviations, CAPA, and documentation systems.
  • Identifying and recommending future improvements.
  • Implementing action plans.
  • Developing quality strategies and priorities.
Required Skills and Qualifications
  • 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.
  • Knowledge of regulations for submission and clinical trials of Investigational Medicinal Products (IMPs).
  • High level of English language, both written and spoken.
  • High level of attention to detail and ability to prioritize working tasks.
  • Strong flexibility in changing tasks and priorities.
  • Ability to work independently and coordinate members of his/her team.
  • Excellent interpersonal skills and ability to work in teams.


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