. JOB PURPOSE: To support the Quality Control Microbiology section in safeguarding the sterility, safety, and quality of pharmaceutical products by performing entry-level microbiological testing, sampling, and environmental monitoring under supervision. The role assists with media preparation, laboratory equipment use, and accurate documentation in compliance with GMP, GLP, approved SOPs, and data integrity requirements, while building the technical foundation and competencies required to progress within the microbiology function. KEY ACCOUNTABILITIES: Microbiological Testing Support • Prepare culture media, reagents, glassware, and laboratory materials for microbiological analysis as per approved SOPs. • Perform or assist in routine microbial limit testing, including TAMC, TYMC, and specified pathogen testing, after required training and authorization. • Support testing of raw materials, packaging materials, in-process samples, finished products, stability samples, and hold-time samples as assigned. • Assist in growth promotion testing, preservative efficacy testing, and microbiological method-related activities under supervision when required. • Assist in sterility testing and endotoxin (LAL) testing activities under direct supervision, after required training and authorization. • Support basic microbial identification activities, including Gram staining and colony observation, under the guidance of senior laboratory staff. Sampling, Water Testing and Environmental Monitoring • Collect, label, handle, and transfer microbiology samples in line with approved sampling and contamination-control procedures. • Support environmental monitoring in production areas and the microbiology laboratory using settle plates, air sampling, and surface monitoring methods. • Assist in microbiological testing of water and utility samples and record results accurately for review. • Support preparation of basic water and environmental monitoring trend summaries as directed by the supervisor. Laboratory Equipment and Culture Handling • Use basic microbiology laboratory equipment such as autoclaves, laminar airflow units, incubators, balances, and refrigerators after training and authorization. • Perform routine equipment status checks, cleaning, and logbook entries, and report abnormalities or out-of-calibration status immediately. • Support media incubation, sample incubation, culture handling, and culture maintenance activities under supervision with proper labeling and traceability. Documentation and Data Integrity • Complete worksheets, logbooks, labels, and laboratory records clearly, accurately, and on time in accordance with GDP and data integrity requirements. • Prepare basic microbiology test reports and submit results for review and approval by the authorized reviewer. • Maintain microbiology files, reports, and controlled documents in an organized and retrievable manner to support audit readiness. Compliance, Safety and Continuous Improvement • Follow approved SOPs, GMP, GLP, biosafety, hygiene, PPE, and contamination-control requirements at all times. • Maintain laboratory cleanliness and support proper disposal of biological and laboratory waste according to company procedures. • Report deviations, abnormal results, contamination concerns, unsafe conditions, or incidents immediately to the supervisor. • Participate in training and competency development activities to build microbiology testing capability and compliance awareness. Other Duties • Perform any other duties within the scope and level of the position, as assigned by the Line Manager, Supervisor, Department Head, or Management, in line with operational and business requirements. QUALIFICATIONS, EXPERIENCE & SKILLS: Qualifications • Bachelor’s degree in Microbiology, Biotechnology, Biochemistry, Biology, Pharmaceutical Sciences, or an equivalent relevant field. Experience • Fresh graduate or 0–1 year of exposure to microbiology, pharmaceutical quality control, or laboratory work. • Academic projects, internship experience, or laboratory training related to microbiological testing, aseptic handling, sample preparation, or GMP/GLP documentation is an advantage. Technical Competencies • Pharmaceutical Microbiology Testing • Aseptic Handling Practices • Sample Receipt, Labelling & Traceability • Culture Media Preparation & Sterilization Support • Environmental Monitoring Support • Water Testing Support • Microbial Limit Testing Support • Sterility & Endotoxin (LAL) Testing Support • Laboratory Records & Logbook Control • SOP, GMP & GLP Awareness • Data Integrity Awareness • Microbiology Equipment Readiness • Biosafety & Microbiological Waste Handling • Basic Microbial Identification & Gram Staining Support Behavioural Competencies • Attention to detail & accuracy • Quality Focus • Ownership, accountability & initiative • Willingness to Learn • Collaboration & teamwork • Clear communication • Planning, prioritization & time management • Integrity, confidentiality & ethics • Safety Awareness
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