Duties and Responsibilities:
- To work as an effective member in the Technical Team consisting of pharmacists, chemists and other disciplines.
- To perform product development activities including pre-formulation studies (such as literature search), formulation development, process development, stability studies and prepare documentations leading to dossier submission.
- To prepare study design and report for NPD for review.
- To prepare necessary documentation for the initiation of bioequivalence (BE) study.
- To assist technical service when necessary to process and manufacturing functions to ensure each product consistently meets specifications.
- To ensure stability study samples are sent for laboratory testing on time.
- To ensure compliance with “Good Laboratory Practice” at all times in the testing laboratories and in accordance to current Good Manufacturing Practices guidelines set by the Malaysian Drug Control Authority.
- To assist in training and supervise laboratory technicians, assistants and junior Executives in carrying out their duties.
- To plan and raise necessary purchasing requisition for necessary products and raw materials for NPD projects.
- To support Technical Services Team during scale up production.
- To support co-ordination of investigational medicine product (IMP) management and handling for BE study.
- To perform other jobs related to product quality which may be assigned to you.
- Bachelor’s degree in pharmacy, science, technology or engineering; preferably with at least five years of experience in production and/or quality control in a manufacturing operation.
- Good communication skill.
- Able to work well in a team environment.