Gmp Production Supervisor
2 settimane fa
**Location: Siena - Italy**
***
**Department: GMP Production**
***
**GMP PRODUCTION SUPERVISOR**
- Supervising department activities in terms of efficiency and training;
- Ensuring department GMP documentation is drafted and updated;
- Ensures compliance with GMP and HSE Instructions during the course of the department’s activities by verifying the proper execution of GMP Instructions;
Supporting the management of investigations, change requests and corrective, preventive or implementation actions for aspects pertaining to the production department;
- Reports to the Production Manager on the efficiency status of departments, equipment rooms and their maintenance and qualification;
- Participating in activity coordination meetings;
- Collaborating with QA to ensure Data Integrity;
- Managing warehouse requests and the progress of processing steps on the plant management system (ERP);
- Preparing the production activity plan for Management approval;
- Reviews, in the first instance, production documentation to ensure compliance with cGMP and departmental SOPs;
- Supporting the selection of suppliers of raw materials/materials and services for the Production department and drafts the URS.
- A MSc/PhD in chemistry, pharmaceutical chemistry, biochemistry, molecular biology, or similar field.
- Excellent knowledge of the UNICORN platform for managing AKTA chromatography systems;
- Excellent knowledge of tangential filtration processes;
- Very good knowledge of GMP;
- Good knowledge of automated stirred-tank fermentation systems (i.e. Sartorius Biostat platform);
- Fast learning ability in the operation of complex automated systems.
Will be considered a Plus:
- At least 5 years of experience supervising a production team working in the GMP area;
- A Good knowledge of English language.
**We Offer**:
**Job location**:
- Sovicille (SI)
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