GMP QUALITY ASSURANCE SPECIALIST

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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:

1. writing, reviewing and approving documents (SOPs, PQRs, IMPDs, validations, research reports, etc.);
2. revision of production and quality control batch records;
3. managing GMP QA operations, change control, deviation and documentation systems;
4. identifying and recommending future improvements;
5. implementing action plans;
6. developing quality strategies and priorities and translating them into short and long-term objectives;
7. risk assessment;
8. interacting with other members of the company and clinical center staff.

The ideal candidate should have:

1. A good scientific background (ideally in Biology, Biotechnology, etc.);
2. Previous experience in Quality Assurance (at least three years);
3. Comprehensive knowledge of GMP and other regulations with a good understanding of global quality standards relating to product development, submission and clinical experimentation;
4. A high level of English language, both written and spoken;
5. A high level of attention to detail and with the ability to prioritize working tasks;
6. A strong flexibility in changing tasks and priorities;
7. The ability to work independently as well as coordinate members of his/her team;
8. Excellent interpersonal skills and ability to work in teams.

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.