Key Responsibility
Prepare documentation of Quality Control as GMP required (e.g. Specification, Test Procedure, Stability Protocol, Standard Operating Procedure, Test Report, Certificate of Analysis)
Responsible for quality control sampling and testing of incoming raw materials and packaging material for manufacturing process.
Perform physical/chemical testing according to Specification and Test Procedure and preparing Test Report
Participate in Method Transfer of new product analytical procedure (as required) to ensure the reliability of testing result - transfer method from R&D Department
Support a group of validation team in the area of laboratory testing for all validation activities
Support Quality Management System to monitoring product quality and ensuring strictly compliance with GMP regulation and other relevant Quality Guidelines such as ICH.
Undertaking any other duties, either for this department or any other department within the business, which may be requested by the QC Supervisor/Manager.
Qualification
Bachelor's Degree in Chemistry,Microbiology or related field.
Work experience, minimum 2 years, in pharmaceutical industry is advantage.
Good knowledge of GMP or GXPs practices.
Experience in ISO/IEC 17025 is advantage.
Basic knowledge and experience with micro laboratory instrument performing analytical tests such as BSC, LAF, Autoclave, Incubator, Sterile Oven.
Good command of English Language.
