Philogen S.p.A. is looking for a “ Qualified Person ” who will report to the Plant Manager.
Key Duties :
* Support direction and management plant operations for Production, Maintenance, and Quality in the development, scale-up, and technology transfer of products, including the production of cGMP products for clinical testing.
* Coordinate plant activities through planning with departmental managers to ensure manufacturing objectives are accomplished in a timely and cost-effective manner.
* Establish and monitor overall plant performance for production and quality standards according to GLP and cGMP guidelines.
* Provide leadership and training to achieve company goals and objectives.
* Implement and maintain preventative maintenance programs.
* Provide direction, development, and leadership to the Production Manager.
* Plan the setup and qualification of a new plant.
Ideal Candidate Profile :
* Previous appointment as a Qualified Person of a plant authorized for the production of medicinal substances.
* Proven experience with inspections by Competent Authorities for relevant authorizations of drug production and release.
* Proven experience in GMP production of proteins or biologics.
* At least three years of experience in the Quality Control unit of a plant authorized for the production of medicinal substances.
* Excellent scientific writing skills and fluency in English.
Work Location :
* Siena