03 set - Latina
Amaris Consulting
Job Description
Job Description
Join our team and start a new adventure in an international and dynamic environment, where you will be able to shape your professional ambitions in a fast-growing organization. As an Amaris consultant, you will position yourself as a technical and functional expert in your field, representing our company with clients, building trustful relationships, and tackling their challenges with competence and passion.
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)
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