Preferred work experience and skills requirements:
1) 1-2 years of experience in logistics, distribution, or warehouse coordination (manufacturing background preferred). Fresh graduates with internship experience of administration can be considered.
2) Knowledge of transport scheduling and local delivery operations.
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Generation and maintenance of Technical Files/Technical Documentations and regulatory submissions to U.S. FDA, EU-NB, Health Canada under supervision. Responsible for ensuring the files are in compliance with relevant regulations and standards.
Assist in regulatory submissions, license applications and amendments (e.g., 510(k), EU MDR, Health Canada) by compiling documents and performing administrative tasks.
Support the organization in change control activities/ product development for potential impact on current regulatory filings for U.S. FDA, EU-NB, Health Canada. Prepare regulatory assessment/submissions as appropriate.
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Develop, identify, experiment, conduct and coordinate validation, verification of proposed materials/ packaging or finished products to ensure their quality and functionality
Participate in Front End Innovation (FEI) activities for the New Product Development pipeline, including market research, concept generation and development.
Own and execute technical deliverables within the project as required.
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To manage and coordinate all construction works at site are completed according to the specifications and standards required.
Responsible for scheduling, planning in detail of the construction works and conducting the technical review of the projects with consultant and higher management.
Close monitor and review all engineering works at site.
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Oversee preventive maintenance programs for manufacturing and plant equipment, including audit readiness.
Monitor equipment lifecycle and ageing trends, and proactively plan and execute mitigation strategies (e.g., refurbishment, upgrades, replacement) to prevent productivity or production impact.
Establish and drive structured competency development plans for engineers and technical staff based on capability gaps and organizational needs.
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To manage and coordinate all construction works at site are completed according to the specifications and standards required.
Responsible for scheduling, planning in detail of the construction works and conducting the technical review of the projects with consultant and higher management.
Close monitor and review all engineering works at site.
...
Supervisory responsibilities and set work direction for a team of lab analysts.
Plan and manage laboratory workload, testing priorities, capacity, staffing, and resources to ensure timely execution of routine testing and project-related activities while maintaining quality and compliance requirements.
Develop and support validation strategies for microbiological test methods, including bioburden and bacterial endotoxin testing, as required to support laboratory and business needs.
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Supervisory responsibilities and set work direction for a team of lab analysts.
Plan and manage laboratory workload, testing priorities, capacity, staffing, and resources to ensure timely execution of routine testing and project-related activities while maintaining quality and compliance requirements.
Develop and support validation strategies for microbiological test methods, including bioburden and bacterial endotoxin testing, as required to support laboratory and business needs.
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Partner with R&D, Marketing, Regulatory Affairs, and Operations to support activities in product and process design such as design verification, design validation, design reviews, design transfer, and all other aspects of a design history file.
Create and maintain risk files consisting of but not limited to risk management plans, hazard and risk analyses, failure mode and effects analyses and risk management reports to assess the risks associated with a product.
Analyze post-market surveillance data periodically throughout a product’s lifecycle to feed back into it’s risk file in order to reflect it's current risk profile. Support Clinical and Medical Writers in the analysis of available clinical data, as required.
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Develop, identify, experiment, conduct and coordinate validation, verification of proposed materials/ packaging or finished products to ensure their quality and functionality
Participate in Front End Innovation (FEI) activities for the New Product Development pipeline, including market research, concept generation and development.
Own and execute technical deliverables within the project as required.
...
Generation and maintenance of Technical Files/Technical Documentations and regulatory submissions to U.S. FDA, EU-NB, Health Canada under supervision. Responsible for ensuring the files are in compliance with relevant regulations and standards.
Assist in regulatory submissions, license applications and amendments (e.g., 510(k), EU MDR, Health Canada) by compiling documents and performing administrative tasks.
Support the organization in change control activities/ product development for potential impact on current regulatory filings for U.S. FDA, EU-NB, Health Canada. Prepare regulatory assessment/submissions as appropriate.
...