Job Description

• Assist in Quality Management System ( QMS ) improvement programs to ensure compliance to applicable legal requirements. QMS and Good Manufacturing Practices ( GMPs)
• Assist in system compliance by reviewing company practices, change control, regulatory documentations such as technical files risk management files, international Organization for Standardization ( ISO ) documentation and other regulatory issues.
• Plan and manage activities such as internal & external audits, regulatory agency inspection , products recalls etc.
• Keep abreast with internal and external mattress industry regulatory news and updates, guidelines, standards etc.
• Facilitate with headquarters Regulatory Affairs ( RA ) and Marketing departments in preparing and reviewing regulatory agencies submission materials to ensure timeliness, accuracy, comprehensive and compliance to regulatory standards. 
• Provide regulatory guidance to factories to ensure manufacturing processes and products distribution comply with the required regulations.
• Follow up on actions plan replies, monitor and evaluate Corrective Action / Preventive Action ( CAPA ) closure effectiveness.
• Provide training and guidance to staff in regulatory procedures and standards.
• Other duties as assigned by management from time to time.

Job Requirements

• Candidate must possess at least Diploma / Bachelor’s Degree in Science, Engineering or equivalent.
• At least 4 Year(s) of working experience in the manufacturing industry is required for this position.
• Preferably candidate specialized in Regulatory Affairs, Quality Assurance or equivalent.
• Demonstrate sound knowledge and experience in ISO 9001, QMS and GMPs.
• Required language(s): English , Bahasa Malaysia, Chinese.
• Possess good communication , leadership and interpersonal skills.
• Willing to work in Kampung Baru Sungai Buloh

Additional Info