Job Descriptions:
- Ensure audit preparedness by preparing the relevant document
- Participate in internal and external audits
- Support verification/validation activities and ensure regulatory compliance based on the outcome of the risk assessment
- Support in developing and preparing documents and activities for: FMEA, Quality Procedure, Work Instruction, verification/validation plan, protocol and report
- Mass manufacturing process verification/validation plan, protocol, and report
- Product filling and packaging process verification/validation plan, protocol, andreport
- Assess the impact of regulatory changes on the company/department: monitor, perform gap analysis, and ensure timely and appropriate reactions to regulatory changes
- Assist in the implementation of optimal regulatory strategies to ensure regulatory and commercial success in the most effective and timely manner
- Participate in formal improvement team activities
- Support all development and organizational improvement initiatives in order to achieve business objectives
- Other tasks as assigned by supervisors/managers
Requirements:
- Minimum 2-3 years working experience in Plastic Injection Moulding particularly in Medical Device Manufacturing industry
- Diploma/Degree in Biomedical/Mechanical Engineering/relevant field
- Experience in Minitab software
- Good communication skills
- Able to work independently
