Chemist

Vacant Position: Analytical Technical Services Chemist / Quality Control Chemist

Workbase: Cheng, Melaka.

Job Outline:

1. Responsible for supporting the designated technical activities of the Analytical Technical Service Department.
2. Focus areas :
3. Product Development – comprises of Analytical Method Development (AMD) and Validation/Verification (AMV), External Liaisons and Analytical Method Transfer (AMT), and Control Strategy from analytical aspects.
4. Compliance – Comprises of Comparative Dissolution Profiling (CDP), Photostability and Stability Study (SS), In-Use Stability Study (IUSS), Maintenance of Analytical Method Lifecycle, Quality Control (QC) of Starting Materials and Certificate of Analysis Generation for Investigational Medicinal Product (IMP).
5. Laboratory Operations – Comprises of Document Management, Digital Enabled Laboratory Project, Consumables Management and Maintenance of Good Laboratory Practice, Personnel Qualification, and Equipment Lifecycle.

Duties and Responsibilities:

1. To lead analytical method development, validation, and verification for new and existing raw materials, packaging materials, and products.
2. To lead analytical method improvements and the development of new testing parameters for existing products.
3. To conduct and oversee impurity analysis in accordance with applicable regulatory requirements.
4. To manage analytical method validation, verification, and transfer activities, including the preparation and maintenance of relevant documentation.
5. To lead investigations into abnormal analytical results and equipment issues, and provide technical support for regulatory submissions and enquiries.
6. To oversee routine laboratory testing and ensure timely completion of analytical activities.
7. To support analytical method lifecycle management, including method assessment, planning, implementation, and continuous improvement.
8. To support cleaning validation and other related technical activities as required.
9. To manage laboratory change control and ensure relevant documents, procedures, specifications, and records are updated accordingly.
10. To support laboratory digitalisation projects, including system implementation, data migration, validation, and qualification activities.
11. To ensure laboratory equipment is properly maintained, calibrated, verified, and fit for use.
12. To manage laboratory supplies, chemicals, reference standards, consumables, and related inventory.
13. To manage laboratory column usage, maintenance, and tracking in accordance with established procedures.
14. To support the evaluation, qualification, and monitoring of external laboratories, including the coordination of outsourced testing activities.
15. To identify and report laboratory safety concerns and ensure compliance with applicable safety requirements.
16. To ensure laboratory activities comply with relevant quality standards, regulatory requirements, and Good Laboratory Practices.
17. To maintain data integrity and ensure laboratory records, raw data, and electronic systems are accurate, complete, and properly maintained.
18. To contribute to continuous improvement initiatives involving laboratory methods, procedures, systems, and practices.
19. To assist with other analytical testing activities and perform any other duties assigned by the Superior.

Minimum Requirements:

1. A Master's Degree or Doctorate in Chemistry or Science or other relevant fields (preferred).
2. At least 2 years of relevant experience as a chemist, familiar with either liquid chromatography, gas chromatography and mass spectrometry equipment.
3. Membership/Licentiateship of the Malaysian Institute of Chemistry or equivalent (preferred).
4. Able to work overtime including weekends when necessary.
5. Good communication and able to work in a team environment.