Job Description

Job Responsibilities:

• Perform routine microbiological testing on raw materials, in-process samples, and finished products, ensuring compliance with established specifications and regulatory standards.
• Prepare and maintain microbiological media, solutions, and reagents in accordance with standard operating procedures (SOPs).
• Conduct environmental monitoring and microbiological assays to assess the cleanliness and sterility of manufacturing areas and equipment.
• Support investigations related to microbiological deviations and assist in corrective and preventive actions (CAPA) implementation.
• Maintain accurate and up-to-date records of all test results and laboratory activities in compliance with Good Laboratory Practices (GLP).
• Assist in the validation and qualification of microbiological testing methods and equipment.
• Collaborate with cross-functional teams to ensure quality and regulatory compliance throughout the production process.
• Maintain laboratory equipment and ensure that it is properly calibrated and functioning.
• Assist in the preparation of reports, stability studies, and regulatory filings as needed.

Qualifications:

• Bachelor’s degree in Microbiology, Biology, or a related field.
• Strong knowledge of microbiological testing techniques, including sterilization, environmental monitoring, and microbial identification.
• Experience with laboratory instrumentation, data analysis, and interpretation.
• Familiarity with regulatory requirements, such as GMP (Good Manufacturing Practices) and GLP (Good Laboratory Practices).
• Strong attention to detail and ability to work independently as well as part of a team.
• Excellent written and verbal communication skills.
• Ability to prioritize tasks and manage time efficiently in a fast-paced environment.

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