Microbiology Laboratory Analyst/Specialist
2 weeks ago
About We are a distinguished pharmaceutical brand with over sixty years of expertise, now expanding regionally in Singapore as our Southeast Asia hub. We are seeking skilled Microbiological Laboratory Analyst/Specialist to ensure the high standards of quality control in our manufacturing operations, supporting both the startup of a new facility and routine QC operations. This role will involve performing microbiological tests, environmental monitoring, and method validation among others, to ensure compliance with GMP, regulatory standards, and internal quality policies. Responsibilities Startup Phase Assist in the setup of the new manufacturing plant and QC lab, ensuring all necessary equipment, materials, testing methods, and procedure are in place for smooth operations. Collaborate with teams to source materials, equipment, and contract laboratories to support microbiological testing and manufacturing needs. Develop and lead Environmental Monitoring (EM) qualification programs and utilities qualification to ensure facility cleanliness and microbial control per GMP standards. Conduct microbiological testing related equipment qualification and method verification to meet GMP standards. Assist with chemistry method validation / verification activities to meet GMP standards, where necessary. Support the establishment of the QC operations, ensuring QC readiness to support testing and release for raw materials, in-process samples, finished products, and environmental samples Support preparations for Health Sciences Authority (HSA) GMP inspections to ensure compliance. Routine Operations Perform routine QC microbiological testing on raw materials, in-process samples, finished products, and environmental samples. Assist in troubleshooting microbiological issues and implement corrective actions when needed. Ensure proper maintenance, calibration, and qualification of microbiological equipment in the lab. Document testing and activities in accordance with GMP guidelines, maintaining accurate records. Write Standard Operating Procedures (SOPs) and testing methods to ensure continued compliance. Stay updated on new microbiological techniques and regulatory changes to maintain high laboratory standards. Qualifications & Skills Bachelor Degree in Microbiology, Biotechnology, Pharmaceutical Sciences, or a related field. Minimum of 3 to 5 years of experience in microbiology within a pharmaceutical or GMP-regulated manufacturing environment. Hands-on experience with microbiological testing, equipment qualification, and environmental monitoring in a QC lab. Strong understanding of QC equipment qualification and validation processes. Familiarity with environmental monitoring (EM) programs and utilities qualification in pharmaceutical manufacturing. Knowledge of microbiological data analysis, interpretation, and reporting. Experience in preparing for and supporting GMP inspections is highly desirable. Excellent attention to detail, communication, and problem-solving skills. What We Offer Competitive salary and benefits package. Opportunities for professional development and advancement. A dynamic and collaborative work environment. #J-18808-Ljbffr
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