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 QAoperations, change control, deviation and documentation systems;
* identifying andrecommending 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 ofEnglish language, both written and spoken;
* A high level ofattention 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.