Your Missions
- Review documentation related to microbiological tests, including bioburden and LAL tests, to verify compliance with required quality standards.
- Evaluate and approve reports of sterility tests and endotoxin tests, ensuring accuracy, completeness, and adherence to procedures.
- Critically analyze laboratory results provided by analysts and draft technical comments or requests for integration/correction.
- Control and monitor microbiological quality control procedures, ensuring they are performed according to current regulations (GMP, ISO).
- Interface with production and quality teams for technical clarifications and to ensure documentation accurately reflects compliance with sterility protocols.
- Review and approve microbiological validation documentation related to instruments and processes.
- Verify, update, and maintain technical documentation and standard operating procedures (SOP), ensuring consistency and compliance.
- Work on a continuous shift including nights .
Your Profile
- Experience with microbiological tests: Bioburden , LAL test, endotoxin detection,
sterility testing.
- Knowledge of GMP and ISO regulations applicable to the pharmaceutical industry.
- 6 months/ 1 year of experience in similar roles in microbiological quality control.
- Analytical and problem-solving skills in regulated environments.
- Precision and attention to detail in laboratory activities and documentation.
- Excellent teamwork and communication skills with various stakeholders.
- Academic background: Degree in Biology or related disciplines (mandatory).
What We Offer
- An international community bringing together 110+ different nationalities.
- An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibility.
- A robust training system with our internal Academy and 250+ available modules.
- A vibrant workplace that frequently gathers for internal events (afterworks, team buildings, etc.).
- At Am
📌 QC Micro Analyst (Italia)
🏢 Mantu Group
📍 Italia
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