GMP Quality Assurance Coordinator
Philogen S.p.A. is looking for a “ GMP Quality Assurance Coordinator ” 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, validation protocols and reports, technical reports, etc.);
* 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 and translating them into short and long-term objectives;
* writing and reviewing risk assessments;
* 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 five years);
* Comprehensive knowledge of GMP and other regulations with a good understanding of global quality standards relating to product development and manufacturing;
* Knowledge of regulations for submission and clinical trials of IMP is a plus;
* 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.
* Preferably previuos experience in coordinating 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.