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To assist the Analytical Chemist / Microbiologist to ensure that all utilities (water, environmental and compressed gas), process raw materials, factory samples, intermediates and final products are analysed and the results recorded in full compliance with current Good Manufacturing Practice (cGMP) and regulatory requirements that meets the defined quality standards. In addition, provide analytical support for non-order fulfilment activities required for the resolution of process and method problems / issues, and the introduction of new measurement technologies and analytical tests. To lead, schedule and test Value Stream specific raw materials, process intermediates, final product, non-routine samples and ENVOPS in accordance to written procedures and methods.
Job Responsibility:
Ensure that all raw materials / factory samples / intermediates / final products / utilities microbiological monitoring / non-order fulfillment and NCE fulfillment activities are analyzed and tested according to the stipulated quality requirements so as to provide accurate test results for correct usage decisions
Ensure that all instruments are in good working order, reagents and reference standards within expiry and that documents meet regulatory standards
Operate the relevant computer applications that are related to the laboratory functions, such as Corporate ERP System, LIMS, Empower and other network operating systems, as required to ensure completion of Corporate ERP System transactions
Use the appropriate documentation system for the activities being carried out
Ensure training records keep up to date
Maintain an excellent standard of housekeeping in the laboratory
Ensure a safe working environment in the laboratory and perform 6S inspection
Troubleshooting of laboratory instruments malfunctions and carries out minor repairs so as to minimize equipment and production downtime
Requirements:
GCE ‘O’ or ‘A’ Level in relevant subjects and/or Diploma in Chemical Process Technology or Applied Chemistry
At least 2-3 years of experience in an analytical environment, preferably in the pharmaceutical industry
Good knowledge of GMP and GLP
Good knowledge of analytical techniques, equipment capabilities and operational needs
Problem solving skills (Troubleshooting skills)
Good communication skills
Willingness and ability to work a 12-hour shift pattern