Executes the activities of QC Microbiology Laboratory by following approved microbiological and chemical test procedures and ensuring their delivery in an accurate and timely manner following proper safety precautions. Also, provide QC microbiology support to the Aseptic Manufacturing and validation process.
Responsibilities
Performs Microbiological Tests and studies by following the established procedures referenced in the official sources
Collection of samples (Raw Materials, Excipients, Validation, In-process, and Finished product samples) for microbiological/chemical testing
Conducts validations studies and routine tests related to Bioburden tests, Bacterial Endotoxin Tests, Particulate Matter Tests, and Sterility Tests
Preparation of microbiological media and diluents by following laboratory procedures
Quality Control Testing of microbiological media and reagents
Environment Monitoring of Aseptic / Non-aseptic Manufacturing areas and Trending of microbial data obtained from EM/Utilities/Raw Materials/In-process and finished products testing and preparing the periodical summary report.
Maintenance of Laboratory inventory
Responsible for maintaining the microbiology isolates obtained from EM and Utility Monitoring Program
Follow established health and safety procedures and policies related to QC Microbiology Laboratory operations. Perform other related duties as required and assigned by Microbiology Laboratory Management.
Qualifications
Must have a thorough understanding of QC Microbiology Laboratory Operations and Sterility Assurance program
Sound understanding of cGMP
Must have a minimum Bachelor's Degree in Microbiology / Biology or related disciplines
Must have 1-2 years of experience as a QC Microbiologist in a Drug/Device manufacturing industry
