Job Description

1. Establishing, managing, planning, scheduling and executing analytical method development in compliance with current regulatory requirements in accordance to current pharmacopeia or in-house method for both finished product and starting materials.
2. Establishing, managing, planning, scheduling and executing analytical method validation as per latest validation guidelines and protocols.
3. Responsible to review the DMF and other analytical procedures along with establishing finished product and starting material test procedures, specification and COA in accordance with latest official monographs/pharmacopoeia.
4. To prepare various analytical reports, including analytical method development reports, method validation protocols/reports, analytical protocols, and investigation reports for finished products and starting materials.
5. To participate in laboratory investigations, out-of-specification investigations, and out-of-trend investigations, and prepare investigation reports accordingly.
6. To prepare responses of analytical-related regulatory queries and conduct various studies, including extractable and leachable studies, nitrosamine risk assessments, and elemental impurity risk assessments, in accordance with current guidelines.
7. Direct assistance on the Validation Team in process validation, cleaning and other qualification or validation, in which laboratory testing support is required and QC team in the execution of test methods during method transfer of newly developed methods/ validated methods.
8. To participate in troubleshooting laboratory equipment failure and provide proposals for improvement.
9. Comply and work towards meeting the Company’s quality, health safety and environment objectives and policies.

Job Requirements

1. Bachelor Degree, Master or PhD in Pharmaceutical, Chemistry, Biochemistry or any science related course.
2. Minimum 3 years hands-on working experience particularly in areas like analytical method development, analytical method validation & analytical testing.
3. Strong ability to conduct experiments, analyse data, and interpret results accurately.
4. In-depth understanding of analytical method development, method validation, drug formulation, analytical testing, pharmacopeia’s and regulatory guidelines.

Skills