Roles & Responsibility
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.
Perform all the QC sampling and analysis of e.g., utilities, raw materials, packaging materials, in-process samples, semi-finished/finished products and environmental monitoring.
Accurately follow the current SOPs and analytical methods and participate in the writing of SOPs and analytical methods. Assist Lab Manager/Supervisor to ensure that all documents in QC Laboratory are current, accurate and comply with cGMP.
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.
Participate in projects, validation works assigned by the Lab Manager/Supervisor.
Be responsible for maintenance, calibration and upgrading of existing instruments and equipments.
Fully trained and competent in cGMP requirements that are applicable to QC Laboratory.
Follow up own training program and train new employees in working methods.
Ensure that corporate and local EHS procedures are followed.
Qualification/Requirements
Relevant Scientific College graduated or above is essential.
Experience in pharmaceutical quality control laboratories and basic knowledge of GMP is desirable.
Knowledge fundamentals of analytical technology is desirable.
Desired Characteristics
Basic knowledge of English.
Knowledge of MS office software.
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