13 ago - Latina
Amaris Consulting
Job Description
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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
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- 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
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- 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 doc
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