LSNE is a leading pharmaceutical Contract Development Manufacturing Organization (CDMO) that specializes in aseptic and non-aseptic fill / finish and lyophilization of biologic drugs, small molecules, suspensions, oily and aqueous solutions, in a wide range of different presentations glass vials, prefilled syringes and ophthalmic bottles.
Perform their duties following quality criteria, health and safety standards.
Perform the functions of their position in accordance with the behavioral values established in the company.
Work in accordance with GMP regulations
Report the work done to the person in charge / technician of microbiological development
Documentary work :
Detection of possible out of specification results (OSS), out of trend results (OOT) and deviations. Collaboration in investigations.
Document the activities carried out following the GMP standards and LSNE Leon work procedures
Laboratory work :
Execution of microbiological tests and analysis (decimal dilutions, sowings, growth control, etc.) according to the established internal methods and procedures.
Interpretation of results.
Perform sampling and analysis of microbiological development of raw materials, bulk product, intermediate product, final product and packaging materials.
Carry out the calibration, verification and maintenance control of the analysis equipment.
Collaborate in the drafting, updating and modification of GMP documentation. Interpretation and execution of GMP documentation applicable to the microbiological development laboratory.
Environmental sampling of clean rooms and personnel.
Management and control of samples.
Control of the material, reagents, reference strains, culture media, etc. used in the microbiological development laboratory and communication to the person in charge of the needs.
Organization and cleaning of the laboratory rooms.
Demonstrable experience of at least 6 months in the microbiology laboratory, performing the functions described.
Experience in bioburden, sterility and endotoxin testing.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification.
They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.