The incumbent will be expected to support implementation of RSTO’s environmental site and corporate SHE programs. Specific programs or areas of work to support include, but are not limited to:
Coordinate site-wide hazardous and non-hazardous waste collections, characterization and storage programs and interfacing with waste disposal contractors’ representatives;
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Support the Biochemical Manufacturing Department by working effectively within the group to meet department goals and objectives.
Responsible for completing assigned tasks which may include preparing small equipment, cleaning and sterilizing vessels, preparing solutions, monitoring and operation biochemical processing equipment, raw materials sampling, dispensing and environmental monitoring sampling and maintain housekeeping of the areas while adhering to Safety, cGMP and Biochemical Manufacturing guidelines.
Assigned tasks must be prioritized and work must be documented per approved manufacturing formulae
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The incumbent will be expected to support implementation of RSTO’s environmental site and corporate SHE programs. Specific programs or areas of work to support include, but are not limited to:
Coordinate site-wide hazardous and non-hazardous waste collections, characterization and storage programs and interfacing with waste disposal contractors’ representatives;
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Environmental Monitoring: Execute routine sampling for critical utilities in accordance to the established EM program. These critical utilities include HVAC, BSC, VLFH/HLFH, compressed air/gas, and water/pure steam systems
Laboratory Operations: Perform routine and non-routine EM sample testing (bioburden testing) in alignment with SOPs and cGMP regulations
Support of Critical Utilities: Support the sampling, testing and timely release of EM results of critical utilities to support production run and mitigate production delay
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Provide QA oversight for RSTO to ensure that investigational medicinal products (IMPs) and commercial medicinal products are manufactured in accordance with global Roche, Pharmaceutical Quality System (PQS) and local site requirements
Responsible for escalation of quality issues following the criteria defined in current governing documents
Support and/or perform routine “Make, Assess, Release” operations to meet targets and timelines
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Comply with all RSTO’s Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable
Observe all RSTO’s site security measures at all times, and report any suspicious characters/objects & damaged security mechanisms to Site Security immediately
Support a strong Engineering and Maintenance Safety Culture that encourages taking the right amount of time to perform each task safely
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Develop Validation SOPs, templates, guidelines, Validation Protocols and Reports including supporting site discrepancies and deviations investigation / closure in line with corporate policies and standards
Provide guidance and direction on all validation activities at the Singapore site
Ensure that all validation activities with respect to process, cleaning, facilities/equipment and computerized system stated in validation plan/ protocol are carried out in accordance with relevant policies, standards, procedures and guidelines, and completed in a timely fashion
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Environmental Monitoring: Execute routine sampling for critical utilities in accordance to the established EM program. These critical utilities include HVAC, BSC, VLFH/HLFH, compressed air/gas, and water/pure steam systems
Laboratory Operations: Perform routine and non-routine EM sample testing (bioburden testing) in alignment with SOPs and cGMP regulations
Support of Critical Utilities: Support the sampling, testing and timely release of EM results of critical utilities to support production run and mitigate production delay
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Responsible for engineering maintenance, repair of all utilities and manufacturing equipment/systems serving the entire manufacturing facility and the execution of all job orders
Troubleshoot and provide technical support to a team of maintenance and calibration specialists on shift to perform engineering maintenance and repair of facilities and manufacturing equipment in support of plant operations.
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