Job Description:

We are looking for a qualified and experienced Microbiology Reviewer / Senior Officer to support microbiological testing and documentation review in an API manufacturing facility. The candidate should have hands-on experience in API microbiology testing, environmental monitoring, and review of microbiological data and records, with a strong understanding of Good Documentation Practices (GDP) and Good Laboratory Practices (GLP). Key Responsibilities 1. API Microbiology Testing and Review  Perform and review microbiological testing of APIs, raw materials, intermediates, process samples, and water samples, as applicable.  Review microbiological analytical data, raw data, worksheets, test reports, and laboratory records for accuracy, completeness, and compliance.  Review microbial limit tests, total microbial count, and specified microorganism testing, as applicable to approved specifications and methods.  Verify test results against approved specifications, standard operating procedures (SOPs), and applicable pharmacopoeial requirements.  Ensure timely completion of microbiological testing, documentation, and reporting.  Identify discrepancies in analytical records and coordinate their resolution with laboratory personnel. 2. Environmental Monitoring  Perform and review environmental monitoring activities in applicable manufacturing and laboratory areas.  Conduct or review viable and non-viable monitoring, as applicable to the facility and established procedures.  Perform or review settle plate, active air sampling, and surface monitoring activities.  Monitor environmental monitoring results against established alert and action limits.  Identify environmental excursions and support investigations, root cause analysis, and CAPA implementation.  Ensure proper documentation, trending, and reporting of environmental monitoring results. 3. Documentation Review and Compliance  Review microbiology laboratory records, analytical worksheets, logbooks, and test reports.  Ensure compliance with GDP, GLP, applicable GMP requirements, and internal quality procedures.  Verify that laboratory documentation is accurate, complete, traceable, and maintained according to approved procedures.  Ensure adherence to data integrity principles and good documentation practices.  Maintain and review records related to media preparation, sterilization, culture handling, and laboratory equipment, as applicable. 4. Quality Management and Investigations  Support investigations related to microbiological failures, environmental monitoring excursions, and out-of-specification (OOS) results.  Assist in identifying root causes and implementing corrective and preventive actions (CAPA).  Participate in deviation investigations and change control activities, as required.  Support internal audits, customer audits, and regulatory inspections.  Ensure compliance with approved SOPs, microbiological testing procedures, and laboratory safety requirements. 5. Laboratory Operations  Ensure proper handling, preparation, labeling, storage, and disposal of microbiological media and cultures.  Verify the suitability and performance of culture media, where applicable.  Ensure calibration, qualification, and maintenance of microbiology laboratory equipment.  Maintain laboratory cleanliness, biosafety, and contamination control practices.  Coordinate with QC, QA, Production, and other relevant departments to resolve microbiological quality issues. Mandatory Requirements  Qualification: M.Sc. in Microbiology.  Experience: 4–6 years in pharmaceutical microbiology, preferably in API manufacturing.  Hands-on experience in API microbiological testing and review.  Practical experience in environmental monitoring and review of monitoring data.  Mandatory knowledge of Good Documentation Practices (GDP) and Good Laboratory Practices (GLP).  Good understanding of applicable GMP requirements, microbiological methods, and laboratory documentation.  Strong analytical, review, documentation, and communication skills. Preferred Skills  Knowledge of pharmacopoeial microbiological testing methods, including relevant IP, USP, or Ph. Eur. requirements.  Experience with microbial limit testing, water microbiology, and environmental monitoring trend analysis.  Familiarity with OOS investigations, deviations, CAPA, and data integrity requirements.