Duties and Responsibilities:
1. To be appointed as Management Representative to manage and ensure all requirements outlined in quality manual are effectively implemented and maintained.
2. To be accountable for the compliances of quality assurance in the plant.
3. To manage and provide strategic planning and execution of quality assurance strategies and procedures to ensure compliance with all applicable regulatory requirements, quality system, Current Good Manufacturing Practice (cGMP) requirements and drive as well as support continuous improvement within the organization.
4. To be responsible for developing and maintaining the quality system to ensure compliance to quality requirements such as maintaining quality system documentation, resolving all matters pertaining to quality and monitoring the quality system to comply with relevant standard and regulatory requirements.
5. To manage, coordinate and support the quality assurance functions to meet ongoing customers’ requirements.
6. To build and maintain good working relationships with customers and suppliers.
7. To oversee, coach and guide the Quality Assurance team.
8. To liaise with government regulatory agencies and bodies, industries associations, research institutes or laboratories and standardization bodies on quality matters.
9. To implement all policies, activities, procedures, instructions as relevant and required by the quality management system.
10. To undertake all other duties and responsibilities as so instructed by the superior.
1. Candidate with at least Bachelor’s Degree in Science (BSc) or equivalent.
1. Candidate with minimum 10 years of related experience in regulated healthcare environment (ISO13485:2016) with at least 5 years of managerial position.
2. Candidate with medical gloves manufacturing process experiences will be preferred.
1. Candidate must possess strong validation or verification skills for equipment and processes.
2. Candidate must be familiar with statistical analysis software tool and MS Office applications.
3. Candidate must demonstrate knowledge in ISO13485:2016 and other quality management systems.
4. Candidate must possess knowledge in risk management processes and relevant regulatory requirements.
5. Candidate must possess well-developed communication and interpersonal skills, both written and verbal in English & Bahasa Malaysia, knowledge of other language will be an added value.
1. Candidate must be able to perform in a high-paced and dynamic environment to meet tight deadlines.
2. Candidate must be self-driven, motivated and open to new ideas and information.