Deputy Qualified Person - Siena, Italia - Philogen
Descrizione
Location:
Siena - Italy
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Department: GMP Production
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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.
- Directing and managing plant operations for Production, Maintenance and Quality in the development, scaleup 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 costeffective 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.
- 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.
Work Location:
- Siena area
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