QC理化检测专员

7 months ago

Kunming, China Bayer Full time

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

QC理化检测专员 

YOUR TASKS AND RESPONSIBILITIES

• Purpose:
• Be responsible for testing procedures/management processes operation (e.g., solution preparation, instrument handling and maintenance) on safety and compliance aspects, ensure data integrity and GMP compliance.
• Be responsible for the method transfer / validation and equipement acquisition / qualification according the multiple pharmacopeia (USP.EP,JP) and golobal regulations(EMEA,FDA,TGA,ICH...).
• Prepare protocol, execution and generate reports accordingly
• Perform lab OOS/OOT investigation, ensure its logical and rational by using scientific tools ( A3R.fishbone .ect) .
• Key Tasks:
• Perform the testing task asigned by QC scheduler on time
• Be responsible for testing procedures/management processes operation (e.g., solution preparation, instrument handling and maintenance) on safety and compliance aspects, ensure data integrity and GMP compliance.
• Perform regular check and update on procedures based on defects and /or gap assessment if necessary.
• Be responsible for the method transfer / validation and equipement acquisition / qualification according the multiple pharmacopeia (USP.EP,JP) and golobal regulations(EMEA,FDA,TGA,ICH...).
• Perform lab OOS/OOT investigation, ensure its logical and rational by using scientific tools ( A3R.fishbone .ect) .
• Roll out PSS related activities as pillar and lab PDCA demands.
• Define safety stock and monitoring the use of lab reagents, reference standards,calibrated galssware ,setting best practice to balance cost, quality, and efficiency
• Responsible for plan, organize outsource testing to ensure compliance with quality requirements and local authority requirements 
• Be responsible for conduct lab consumables management, including but not limited to define right place vs SAP, manage safety stock to ensure lab business continuity.
• Be responsible for the analyst trianing and qualification.
• Other tasks assigned by line manager

WHO YOU ARE

• Education：Bachelor’s degree or above in analytical chemistry or pharmacy related majors
• Experience：5+ years pharmaceutical lab experience
• Skills：
• Familiar with pharmacopeia (e.g., Ch.P, EP and USP etc.), 
• Familiar with cGMP, EU GMP, FDA and ICH regulations
• Familiar with computerized system, lab instruments (HPLC, GC,ect) and Analytical techniques
• Good cordination, communication skills and good English skills
• Good learning ability and result orientation, accuracy, ect.

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