GMP QUALITY ASSURANCE SPECIALIST

4 settimane fa

Siena, Italia Philogen A tempo pieno

Job Title: GMP QUALITY ASSURANCE SPECIALIST

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;

- 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 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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