รายละเอียดงาน1.Lead the laboratory personnel responsible for sampling, receipt, storage, testing and disposition of samples of raw materials, packaging components, in process samples, drug substance, drug product and stability study.
2.Review test results of raw materials, packaging components, in process samples, drug substance, drug product and stability study and release the results and manage to ensure that the laboratory testing, analytical method validation and results are released on time.
3.Coordinate with team to conduct the testing activities relevant to GMDP and drug registration requirements. Plan and determine necessary resources for analytical method development and validation.
4.Initiate plan of laboratory performance test, arrangement for performing the test and authorize laboratory personnel for testing of raw materials, packaging components, in process samples, drug substance and drug product and stability study.
5.Manage laboratories to ensure compliance to Good Documentation Practice, Good Laboratory Practice, Data Integrity, GMP and ISO/IEC 17025 of the laboratory personnel.
6.Manage deviation, non-conformance, OOS, change, out of specifications, risk assessment and other quality management system regarding GMP and ISO/IEC 17025. Lead quality control team for investigation and define correction, corrective action and preventive action to eliminate nonconformities of laboratory testing works.
7.Create, revise, review quality documents relevant to Laboratory activities such as Quality Procedure, Standard Operating Procedure, Test method and specification (Quality Specification), protocol and report and control to ensure that the Good Documentation Practice are followed and maintained.
8.Manage to ensure that the test method and specification are always in compliance with current Pharmacopoeia.
9.Review calibration and qualification report of Laboratory equipment. And manage the laboratory equipment/instrument to ensure the calibrated and qualified.