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Perform microbiological sampling and analysis of finished goods, raw materials, water samples, WIP samples and C&S swabs and environmental samples in accordance with standard procedures.
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Be responsible for all sampling and monitoring program for both lab and plant.
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Plan and manage microbiology lab equipment calibration and routine monitoring as per QMIC 0024.
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Ensure the media QC is carried out in accordance with QMIC 0015 and QMIC 0016.
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Serve as site MPI user and update the finished goods MSI data and water MSI into global MPI system.
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Plan and maintain enough stock of operational supplies such as microbiological media, reagents, API kits and standard culture.
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Oversee the revalidation and validation of the lab equipment in accordance with QMIC 0050.
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Understand and use basic laboratory safety equipment and instructions, precautions in handling reagents and disposal of microbiological waste according with local environmental regulations.
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Understand and precisely follow written lab procedures, global methods, local methods and published standard or compendia sources.
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Participates in failure investigations to collect the necessary samples when appropriate. Acquires basic knowledge of plant floor operations and equipment.
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Apply appropriate methodologies and data interpretation techniques to assist in overcoming technical difficulties and promote continuous improvement.
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Perform or assist the vendor during the installation qualification (IQ), operation qualification (OQ) and performance qualification (PQ) of the analytical instruments.
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Maintains the laboratory quality control systems to assure validity of data.
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Maintain awareness of regulatory and GMP requirements relevant to job responsibilities.
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Maintain accurate, up to date and concise laboratory notebooks and records.
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Perform other related duties as assigned by supervisor.
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Maintain working area, instruments, equipment clean, neat and tidy.