Assist in project implementation and supervision of on-site construction progress.
Prepare relevant reports as required by the Project Manager.
Liaise and coordinate with consultants and contractors, responsible for the overall coordination of the project, including project planning, budgeting and cost control, and the implementation of safety and quality systems.
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Assist in project implementation and supervision of on-site construction progress.
Prepare relevant reports as required by the Project Manager.
Liaise and coordinate with consultants and contractors, responsible for the overall coordination of the project, including project planning, budgeting and cost control, and the implementation of safety and quality systems.
...
Assist in project implementation and supervision of on-site construction progress.
Prepare relevant reports as required by the Project Manager.
Liaise and coordinate with consultants and contractors, responsible for the overall coordination of the project, including project planning, budgeting and cost control, and the implementation of safety and quality systems.
...
Assist in project implementation and supervision of on-site construction progress.
Prepare relevant reports as required by the Project Manager.
Liaise and coordinate with consultants and contractors, responsible for the overall coordination of the project, including project planning, budgeting and cost control, and the implementation of safety and quality systems.
...
Conduct root cause analysis (RCA) and implement Corrective and Preventive Actions (CAPA) using quality tools such as 8D, 5 Why, Fishbone, SPC, and MSA.
Support NPI activities, First Article Inspection (FAI), process validation, risk assessment, and production readiness activities.
Manage supplier quality activities including supplier evaluation, qualification, audits, performance monitoring, and improvement actions.
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Coordinate with Project Managers, Site Engineers, consultants, clients, and subcontractors on all quality-related matters.
Monitor and inspect civil, electrical, and mechanical works including equipment foundations, battery container installation, cable works, electrical equipment installation, testing, and commissioning activities.
Verify materials, equipment, and components delivered to site comply with approved specifications, certificates, and project requirements.
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Responsible for assisting and maintaining a system in accordance with Good Manufacturing Practice (GMP) and Good Distribution Practices (GDP) guidelines in all production areas and stores.
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Routine production audits : Routine production audits are conducted on single-board and complete machine workshops. For any abnormal issues discovered during the audits, corrective measures are followed up and tracked throughout the process until the problem is closed.
Production control in the complete machine workshop : supervise and review the first piece inspection of each work order and the material verification work when switching production lines to ensure that the assembly process of the complete machine meets the quality requirements.
Engineering Change ( EC ) Implementation Verification : Verify the compliance of the implementation of engineering changes ( EC ) in production work orders to ensure that the changed materials, processes, and documents have been correctly implemented on the production line.
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Review product labels, packaging artwork and product information to ensure regulatory compliance. Maintain accurate regulatory documentation, databases and product registration records.
Keep updated with changes in pharmaceutical regulations, guidelines and industry requirements. Support audits and inspections by preparing regulatory documents when required. Assist in preparing Standard Operating Procedures (SOPs) related to regulatory activities. Perform any other duties assigned by Management. Export market Regulatory work and product registration process also having understanding on eCTD.