The R&D junior chemist is responsible for executing stability studies to ensure product quality, safety and regulatory compliance. This role also supports new product development activities to ensure the continuous and efficient workflow of NPI processes, in accordance to PIC/S GMP, ISO13485, and Halal Compliance.

Responsibilities :

1. New product and material study

Develop test methods and quality specifications, for both raw materials and finished product, in alignment with regulations.
Prepare and maintain technical documentation required for regulatory submission.
Support research, stability study and trials to improve product performance and troubleshoot process deviations.
Ensure traceability through complete and accurate data logging of all incoming R&D materials and products.

2. Stability study

Implement stability study for new and existing products in accordance to regulations, which include relevant laboratory tests, ensuring data accuracy and interpreting results.
Liaise with external laboratory for outsource testing and ensure timely completion, including the documentation of PR, PO, DO and INV.
Maintain accurate documentation including POA, COA, raw data, summary, and schedule master-lists.
Participate and liaise with superior and QA/QC in Out-of-Trend (OOT) and Out-of-Specification (OOS) investigations, including root cause analysis and corrective actions.
Plan and ensure adequate samples and consumables availability throughout stability study period and other related study (if needed).

3. General responsibilities

Monitor instrument (where applicable) and ensure that the instrument is within valid calibration and maintenance periods.
Maintain workplace organization and cleanliness in accordance with 5S principles.
To undertake any other duties as assigned from time to time by the immediate superior.

THP Medical Sdn. Bhd.