Qualified Person
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
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