Production manager (Fill&Finish)
Descrizione dell'offerta
We are looking for a Production Manager (fill & finish) for one of the world's leading contract manufacturers and developers for the pharmaceutical industry.
Responsibilities
- Support 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.
Profile
- Bachelor’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 spoken
Annuncio valido fino a: 31-Mar-2026
#J-18808-Ljbffr