锦鲤求职岗位描述
YOUR TASKS AND RESPONSIBILITIES
In addition to implementing laboratory safety (EHS) requirements, focus on key safety risks, drive effective execution of safety practices in routine laboratory and technical activities, and follow up on safety issue resolution to support sustained safe laboratory operations.
Independently test bulk, stability test samples, validation samples (including production validation and cleaning validation), and cleaning monitor samples according to approved test procedures and specifications.
Implement analytical transfer, verification, and validation.
Perform operation, calibration, and maintenance of related analytical instruments according to BHC SOPs.
Revise SOPs, test procedures, or other documents according to BAG directives, regulations, SOPs, Pharmacopoeia requirements, or registration specifications.
Review documents, records, and data related to QC.
Identify routine abnormalities or trends, escalate promptly, and support deviation or laboratory investigations.
WHO YOU ARE
Bachelor’s degree or above in Pharmaceutical Analysis or a related field.
At least 3 years of working experience in a pharmaceutical plant is preferred.
Familiar with Chinese GMP, EU GMP, data integrity requirements, pharmacopeias, regulations, and guidelines related to QC activities.
Familiar with commonly used laboratory analytical instruments and relevant software systems, with strong data analysis and technical judgment capabilities, such as LIMS, Empower, HPLC, GC, IR, and UV.
Knowledge of Chinese GMP, Chinese Pharmacopoeia, and European Pharmacopoeia.
English in written and reading.
Strong team work spirit.
Good team spirit.
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