Job Description

"1. To work as an effective member in the Technical Team consisting of pharmacists, chemists and other disciplines 2. 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. 3. To prepare study design and report for NPD for review. 4. To prepare necessary documentation for the initiation of bioequivalence (BE) study. 5. To perform process validation at pilot or commercial scale for new product and reformulation projects. 6. To prepare developmental documents for approval of Clinical Trial Exemption (CTX) for bio-batch manufacturing of new product required for clinical study. 7. To provide technical service when necessary to process and manufacturing functions to ensure each product consistently meets specifications (if required). 8. To prepare stability study protocol and ensure stability study samples are sent for laboratory testing on time. 9. 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 or relevant regulatory bodies in the conduct of formulation developmental work. 10. To manage and maintain clinical affairs policies and standard operating procedures (SOPs) within Xepa-Soul Pattinson (Malaysia) Sdn Bhd 11. To engage in the selection and qualification of new centres / sites for BE / clinical studies 12. To coordinate investigational medicinal product (IMP) sourcing, management and dispatch handling for BE / clinical studies 13. To assist in training and supervise laboratory technicians, assistants and junior Executives in carrying out their duties. 14. To perform material planning for necessary products and raw materials for NPD projects. 15. To support Technical Services Team during scale up production. 16. To maintain and upkeep project development files and ensure compliance with ISO Management System. 17. To prepare Analytical Data Sheet and assist analytical documentation system management 18. To perform other jobs related to product quality which may be assigned to you."
Founded in 1967 in Singapore, Xepa has grown and evolved at the cutting edge of the industry. From our modest first years when Xepa Laboratories Pte. Ltd. produced a limited range of pharmaceutical products in a small flatted factory, we have relocated twice to larger manufacturing plants in Melaka, Malaysia. Today, Xepa is the leading manufacturer of off-patent pharmaceuticals in Malaysia.
Bachelor\'s or Equivalent