DEPUTY QUALIFIED PERSON
Philogen S.p.A. is accepting applications for the position of Deputy Qualified Person
Deputy Qualified Person reports directly to the Plant Manager and works collaboratively with other Business Units to scope, plan, and execute new business opportunities.
In particular, the successful candidate will support the Plant Manager in taking care of:
- Directing and managing plant operations for Production, Maintenance and Quality in the development, scale-up and technology transfer of products.
- Coordinating plant activities through the planning with departmental managers to insure the total manufacturing objectives are accomplished in a timely and cost-effective manner.
- Establishing and monitoring overall plant performances for production and quality standards according to good laboratory practices (GLP) and current good manufacturing practices (cGMP) guidelines.
- Implementing and maintaining preventative maintenance programs.
- Providing direction, development and leadership to the Production Manager.
Candidates should have the following profile:
- Proven experience in the management of a Department of a GMP plant.
- Proven experience with inspections by the Competent Authorities for relevant authorizations of the production and release of drugs.
- Proven experience in the GMP production of proteins or biologics.
- BS/MS/PhD in Pharmaceutical Chemistry, Pharmacy, Chemistry, Biology, Medicine or Veterinarian Medicine.
- At least one year of experience in the Quality Control unit of a plant authorized to the production of medicinal substances.
- Excellent scientific writing skills and fluency of the English language.
- Previous appointment as Qualified Person of a plant authorized to the production of medicinal substances is preferred but not mandatory.