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Job Responsibilities
- Ensure raw materials, in‑process, utility, base powder and finished goods samples are tested timely to meet TAT according to established test methods, technology and quality requirements, including sample compositing for both base and finished goods.
- Maintain microbiology laboratory in good manner, applying GLP, GDP and GMP principles.
- Support root cause analysis for OOS, deviations, atypical or invalid results investigations.
- Assist with Method Verification and Method Validation as required, supporting Global Analytical Method Harmonization activities (method transfer and implementation).
- Collect and analyze routine and non‑routine Environmental Monitoring samples (swab, air sampling, water samples) to ensure plant hygiene.
- Maintain current, complete, legible notebooks and laboratory records in compliance with GLP.
- Maintain housekeeping standards (5S practice), observe safety requirements and Good Laboratory Practice in the laboratory, complying with company and regulatory standards.
Job Requirements
- Bachelor's degree in Microbiology or related field.
- 1 to 3 years of relevant laboratory or microbiology experience, preferably in a regulated industry.
- Familiarity with cGMP, GLP and regulatory guidelines.
- Experience with microbial identification techniques.
- Strong attention to detail and documentation accuracy.
Seniority level
Employment type
Job function
- Research, Analyst, and Information Technology
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