Production Manager

2 giorni fa

LATINA, Italia Jefferson Wells A tempo pieno

We are looking for aProduction Manager (fill & finish)for one of the world's leading contract manufacturers and developers for the pharmaceutical industry.ResponsibilitiesSupport the implementation and qualification of the new department and sterile production line, with a focus on isolator technology.Manage the formulation, filling, and packaging activities for injectable products in a sterile environment.Draft and revise department documentation, including SOPs (Standard Operating Procedures) and operational protocols.Manage process deviations and OOS (Out-of-Specification) results, investigating causes and implementing appropriate CAPA (Corrective and Preventive Actions).Ensure the training and ongoing education of staff on operational procedures and new technologies.Supervise and coordinate a team of production operators and technicians.Plan and organize work shifts to ensure optimal coverage.Ensure compliance with cGMP (Good Manufacturing Practices) regulations and internal quality standards.Monitor operational and financial KPIs for the department, identifying and implementing corrective actions to optimize efficiency.Collaborate with the Engineering, Quality, and Maintenance departments to resolve issues and improve processes.Manage internal interactions as well as external interactions with Clients, Regulatory Bodies and Suppliers.ProfileBachelor's degree in engineering (preferably Chemical, Industrial, or Biomedical), Chemistry, Industrial Chemistry, CTF (Pharmaceutical Chemistry and Technology), or equivalent scientific/technical disciplines.Solid experience (minimum 3-5 years) in supervisory or production management roles within the pharmaceutical or biotechnology sector.Proven direct experience in managing sterile production and "fill and finish" processes for injectable biological products.Direct experience with isolator technology is a preferred requirement.In-depth knowledge of cGMP regulations (including FDA and EMA).Excellent leadership, problem-solving, and communication skills.Fluent in English and Italian, written and spokenAnnuncio valido fino a: 31-Mar-****#J-*****-Ljbffr

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