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· Responsible for daily production line audit, managing the document control process for Quality Management Systems in compliance with ISO 9001/14000 and TS 16949 quality standards.
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Communicates and collaborates Shift Manager / Production Support for all the operations to be executed, in solving any anomalies occurred and suggesting possible solutions
Autonomously assures the regularity of the production operations (reactions, distillation, transfers etc. etc.) verifying on the control panels and control instruments (DCS, alarms, etc.) the process parameters
Collaborates with the Warehouse to pick up materials (raw material and / or process solvents) from delivery areas, to the shop floor communicating also to the Shift Manager, critical situations (quantities verification, codes, batch number, etc.)
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Review lot release data, identify testing discrepancies and participate in laboratory investigations.
Participate in inspection and ensure that the laboratory and documents are in a constant state of regulatory compliance and inspection readiness.
To assist in writing SOP documents, Change plan or change records (document revisions) supporting continuous improvement of test procedures and assay sheet design.
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Responsible to develop and execute test scripts using protocols such as Web (http/html), web services, SAP, Java user using MF Performance Centre
Responsible to create & execute test scenarios as per agreed workload model using MF PC or any other performance testing tool such as JMeter.
Responsible for application performance monitoring either using industry wide APM tools such as Nimsoft, Appdynamics or OS commands such as perfmon, Nmon etc.
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Responsible for completeness of documentation prior to release of finished products under New Product Development (NPD), cost / quality compliance project with complete Authorization for Product Release (APR) / Global Change Control (GCC) and meeting quality requirement.
Ensure Validation activities such as Equipment & Facilities Qualification, Process Validation, Computer System Validation, etc. of the site are planned and carried out in accordance to Validation Master Plan and Kenvue requirement
Performs review, trending, tracking and monitoring of cGMP processes, procedures, training, documents and records, including but not limited to non-conformance records, change control, and corrective actions / preventive actions (CAPA), complaints investigation through respective electronic platform systems
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Ensure compliance with all established SOPs while contributing to the development of new procedures to improve safety, hygiene, and operational efficiency.
Assist in carrying out regular inspections and monitoring of raw materials, work-in-progress items, and finished products.
You are required to maintain proper documentation and records related to your responsibilities in accordance with generally accepted practices.
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