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QC Expert 

 

YOUR TASKS AND RESPONSIBILITIES

 

Be responsible for the management of QC related activities cascaded from site NPI and TT projects, ensure they can be implemented logically, rationally and in timely manner through master plan Be responsible for project pre-assessment, including but not limited on lab availability, regulatory/Compliance readiness, investment, resources estimation Be responsible for prepare and/or review lab risk assessment, transfer or implementation strategy and document/SOP Closely coordinate with lab task leader to define proper people with clear R&R, assessing and define detail work plan and deliverables from high level project master plan Monitor project progress and deliverable, including milestone, key KPI, manage change, risk assessment, adjust based on feedback and ongoing status to ensure timeline, deliverable achievements Acting as window person between site project lead and lab manager, lab task leader, to ensure effectiveness, transparency communication Buildup project problem solving, escalation process to ensure problems are properly identified, risk assessment and solutions are effective, and escalated to the right person at the right time Align with lab manger, lab task leader, and communicate with right stakeholder, to ensure project progressing smoothly once project conflict with other business Be responsible for the management of procedures/processes of Empower, Lab X and LIMS, by the consideration of DI and quality aspects, ensure they can be implemented logically, rationally and integrity in lab and continues to optimize Be responsible for design and planning preventive maintenance activities and calibration tasks,build up the rules with task leader to ensure the smoothly organize and implementation Assessing and implement the design of equipment lifecycle management, ensure proper PM/Calibration items/frequency selected to fulfill lab daily operation demand Master QC DI activities, ensure assessment conclusion and issues, CAPAs are shared / executed in timely manner to fulfill lab/site operation demand, ensure those systems runs in a compliant way. Responsible for SAP master data maintain (Specification, inspection plan, PM, Calibration), ensure data accuracy and proper implementation strategy Other tasks assigned by line manager

 

WHO YOU ARE

 

Bachelor’s degree or above in analytical chemistry or pharmacy related majors 5+ years pharmaceutical lab experience SkillsFamiliar with pharmacopeia (e.g., Ch.P, EP and USP etc.), cGMP and ICH Familiar with computerized system, lab operation system, equipment and Key KPI Good leadership, cordination, communication skills Good learning ability and result orientation, accuracy, ect.

 

YOUR APPLICATION

If your background and personal experience fit this profile, please send us your complete application at www.career.bayer.cn If you have any recommendations, please kindly send mail to cnreferral@bayer.com
 

 

Location:                   

China : Yun Nan : KunMing 

 

Division:

Consumer Health 

 

Reference Code:

828073