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.
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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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To drive the lorry to support company to transfer the stock between warehouse side, Mafipro Sdn Bhd, Guinea Foods Sdn Bhd & SFI Food Sdn Bhd on daily basis.
To drive to supplier or government as requested by company and superior from time to time.
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Process monthly payroll accurately and within established timelines.
Verify payroll inputs, including new hires, resignations, salary adjustments, overtime, shift allowances, attendance, leave deductions, bonuses, and other payroll transactions.
Ensure payroll calculations are accurate and compliant with company policies and statutory requirements.
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To maintain the seamer machine in clean and workable condition at all time and carried out in safe manner in concurrently with using PPE provided by company.
To prepare the seamer machine and carry out double seam checking in daily basis before start for real production.
Responsible to carry out seamer setting if found any result of double seam which out of acceptable range.
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To supervise a team of worker, planning of manpower and to ensure smooth production.
To ensure that standard operation procedure is being followed during production.
To work together with QC personnel to ensure products are manufactured under safe & wholesome manners with compliances to GMP, ISO & HACCP and other regulatory standards.
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Jointly responsible to record electricity usage, cold and chiller room temperature into the record book in daily basis or frequency maybe increase from time to time if requested by the superior.
Job scope which including welding, grinding, cutting, painting, plumbing, fabrication, modification, installation, up keeping, corrective and preventive maintenance for factory installations, machineries, equipment, hygienic, environmental and carried out in safe manner in concurrently with using PPE provided by company.
Fully in charge to carry out troubleshooting, repair, maintenance of factory air conditioner, cold room and chiller room equipment.
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To advise the employer or any person in charge of a place of work the measures to be taken in the interests of the safety and health of the persons employed in the place of works.
To assist the safety and health committee in any inspection of the place of work for the purposes of checking the effectiveness and efficacy of any measures taken in compliance with All related Act, Regulation and Guideline.
To inspect the place of work to determine whether any machinery, plant, equipment, substance, appliances or process or any description of manual labour used in the place of work.
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To advise the employer or any person in charge of a place of work the measures to be taken in the interests of the safety and health of the persons employed in the place of works.
To assist the safety and health committee in any inspection of the place of work for the purposes of checking the effectiveness and efficacy of any measures taken in compliance with All related Act, Regulation and Guideline.
To inspect the place of work to determine whether any machinery, plant, equipment, substance, appliances or process or any description of manual labour used in the place of work.
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Preferred work experience and skills requirements:
1) 1-2 years experience in administrative, sales support, or customer service role. Fresh graduates with internship experience of administration can be considered.
2) Proficiency in Microsoft Office and ERP system data entry.
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