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工作職責




* Formulation Testing Team’s task include testing samples of routine,
stability, monitoring, validation and unexpected investigations. Test
supporting work include establishing test procedure, SOP and validation
protocoland report, equipment qualification/calibration maintenance and
consumers management.
* Lead internal and/or external audit on IT system to guarantee the quality
assurance system in compliance with cGMP, international/local regulation, etc..
* As local leader of the ESC project, coordinate headquarters to implement
the project in different relevant Bayer overseas sites. To guarantee the whole
Bayer import products can meet Chinese government regulation, to support the
company’s business development.
* Coordination the compendial coordinator to monitor Chinese Pharmacopoeia
upgrade and follow up decision from RMCA that assure Bayer are in the
compliance position.
* Lead team to give strong technical support to other departments including
Regulatory department and Government affair department.
* To maintain good relationships between BHC and Local authorities by
cooperation with local authorities. Such as Cold Chain, ESC , and computerized
system related workshop.
* Assist QC manager to audit supplier, ensure the audit result truly and
reliable.



任職要求




* Pharmaceutical analysis or related degree of bachelor or above
* At least 8 years working experience inpharmaceutical plant is better
* English in written and reading
* Knowledge on Chinese GMP, Chinese Pharmacopoeia and Europe Pharmacopoeia
* Good operational skills on lab instruments (HPLC, GC, IR, UC etc.);
* Strong team work spirit
* Good communication skill