Job Scope
Your MissionPerform microbiological testing of incoming material, processing intermediates, finished components and auxiliary material
Main Responsibilities
Your ContributionsPerform microbiological analytical determinations using laboratory instrumentation, related to:
- Microbial load of finished products, process waters, plastic materials
- Sterility tests on intermediate products, culture media and plastic materials.
- Monitoring of the microbial load in the air of processing environments, work surfaces and clothing of personnel
- Testing of biological indicators of sterilization
- Management of microbial identification through sowing on culture media, preparation of slides for fresh and Gram staining, visualization under an optical microscope, preparation of API System galleries
- Preparation of culture media
- Filters integrity control
- Approval of raw material of external purchase (document control, sterility and fertility control)
- Management of analysis through dedicated software management of laboratory reagents and consumables
- Management of laboratory reagents and consumables
- Internal validation of laboratory equipment
- Drawing up operational procedures, validation plans, validation protocols and report
- Management ofnon-compliance, OOS (out of standard), RFC (Request for Change), CAPA
Qualifications Experience Personal Strengths Mobility
You Education Bachelors Degree Specialization Biomedical Laboratory Techniques, Microbiology or equivalent qualification Experience0-2 years of experience in related field
Technical CompetenciesGood knowledge of the main microbial characterization techniques
Good manual sowing of the plate
Good knowledge of the use of optical microscope, pH-meter, analytical balance
Good ability to work in sterile conditions under laminar flow hood
Knowledge of microbial load tests by filtration
Knowledge of sterility tests by filtration / direct seeding
Knowledge of environmental control analysis (air, water, surfaces)
Ability to prepare buffers and solutions.
Good knowledge of standard IT tools
Good documentation editing skills.
Good knowledge of GMP / cGMP and guidelines (ICH, FDA)
SkillsCreative/innovative mindset
Planning and organizational skills
Goal orientation
Team working
Learning agility
Languages Good knowledge of English is a preferred Travel Availability N/A Relocation Availability N/A Training RequiredInduction Program Once Hired
**Benefits**:
We Offer YouAs for Company Policy