Responsible for performing and reporting of routine analytical tests in the QC Laboratory according to the specifications; drafting/revising/reviewing SOPs, methods, specifications, training modules and validation documents; translating methods; training new analyst and following up the corresponding analyst’s work in the QC Laboratory. Responsible for both performance and arranging tasks of all the QC sampling and testing of e.g., utilities, raw materials, packaging materials, in-process and semi-finished/finished products, and environmental monitoring as well. Be responsible for both performance and organizing the maintenance, calibration and upgrading of existing instrument and equipment. Participate in new global/local projects and take part in the validation work throughout the plant, in which QC resources are required. Complete required validation documentations. Ensure that all the raw data during the testing are correctly recorded down and all results or testing investigation summary are made completely and timely. Ensure all the records including journals, files and LIMS entry are checked and approved. Assist Lab Manager/Supervisor to ensure that operating in QC Lab is in Compliance with cGMP or relevant regulations/guidelines, GEH/Corporate quality/safety standard, in terms of documentation, sampling and testing. Be able to finish the task arranged and required by Lab Manager/Supervisor. Ensure that corporate and local EHS procedures are followed.
Qualification/Requirements
Relevant Scientific College graduated or above is essential. Experience from pharmaceutical quality control laboratories and basic knowledge of GMP is desirable. Knowledge fundamentals of analytical technology is desirable.
Desired Characteristics
Good knowledge of computer and English. Good communication and leadership skills. Strong problem-solving skills.
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