Regulatory Affairs jobs in Malaysia

Our client specializes in the research, development, production, and sales of daily chemical raw materials, including cosmetic active ingredients, raw materials, and synthetic perfumes. They operate two major production bases in Suqian City, Jiangsu Province, and Ma'anshan City, Anhui Province. The Ma'anshan City production base, through its subsidiary, was constructed according to GMP guidelines for APIs and has passed the FDA on-site audit.

Job Description:

• Lead the development, updating, and continuous improvement of the company's equipment system documentation, as well as the associated management systems and procedures.
• Oversee the entire lifecycle of new equipment, including research, selection, procurement, installation, commissioning, acceptance testing, and post-installation evaluation during the warranty period.
• Manage and maintain accurate and comprehensive equipment records and data.
• Collaborate in the selection, design, manufacturing, and acceptance of new technologies, processes, and equipment as part of technical upgrades and transformations.
• Identify and eliminate equipment defects through systematic analysis, optimization, and upgrades, enhancing overall equipment performance, maintenance quality, and reducing associated maintenance costs.
• Develop and manage annual and monthly preventive maintenance schedules and major repair plans, ensuring their proper execution.
• Perform daily maintenance management, conduct regular inspections, and address unexpected equipment failures promptly and efficiently.
• Handle equipment accidents, organize root-cause analysis meetings, and develop corrective actions and preventive measures.
• Regularly assess spare parts inventory for instrumentation and equipment, formulate procurement plans, coordinate acceptance and allocation of parts, and create emergency procurement plans for critical maintenance needs.

Job Requirement:

• Bachelor's degree or higher in Chemical Engineering, Mechanical Engineering, Electrical Engineering, or related disciplines.
• Minimum of 6 years of experience in the chemical or manufacturing industries.
• Strong knowledge of chemical engineering fundamentals, mechanical and electrical equipment, factory equipment management, labor laws, and safety production regulations.
• Excellent communication, project management, professional, and planning skills.
• Proficiency in English, Chinese, and Malay.