职位详情
国籍要求:马来西亚
职位描述
Key Responsibilities
1. Supervise manufacturing personnel and activities (Drug Product, Drug Substance, and Packaging) to ensure timely GMP-compliant production with minimal to zero deviations;
2. Develop and execute daily manufacturing schedules to meet production targets and timelines;
3. Oversee and monitor day-to-day manufacturing operations, ensuring full compliance with cGMP standards and procedures;
4. Prepare and maintain production documentation, including SOPs, Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR);
5. Operate manufacturing equipment in accordance with established SOPs and safety requirements;
6. Demonstrate and uphold adherence to GMP standards and safety procedures at all times;
7. Report and coordinate with the Head of Centre and relevant teams on equipment troubleshooting, preventive maintenance, and repair activities before and during operations;
8. Execute and monitor critical processes, including routine validation protocols and work orders;
9. Update and inform the Head/superior on project progress, data transfers and process-related developments;
10. Execute and review batch records in accordance with GMP and site quality standards;
11. Perform cleanroom changeover and activation in compliance with established procedures;
12. Support QA (Validation) and Engineering teams in equipment start-up, testing, and qualification activities;
13. Generates and record in production documentation such as Batch Records, SOPs and Protocols as required; and
14. Undertake ad hoc and other duties as assigned from time to time.
Qualifications and Experience:
1. Malaysian citizens;
2. Minimum Bachelor’s Degree/Professional Degree in Engineering/Science or any related field and recognized by the Malaysian government from a local or foreign higher education institution or a qualification recognized as equivalent;
3. Preferably with a minimum one (1) year experience in GMP and cleanroom facility;
4. Strong communication, organizational and problem-solving skills;
5. Ability to work independently in a structured and regulated environment; and
6. Proficient in Microsoft Office (Word, Excel, Powerpoint).
Benefits and Opportunities Offered
At NIBM, we value our employees as the organisation’s most important asset. In this role, you will have the opportunity to:
Contribute to the development and management of the organisation’s human capital.
Work in a collaborative, dynamic environment that supports continuous learning.
Enjoy competitive rewards and compensation.