Pharmaceutical Quality Control Specialist

1 month ago

Kunming, Yunnan, China Bayer Full time

About Bayer


Bayer is a leading global healthcare company that discovers, develops, and delivers innovative solutions to help people live healthier lives. We're driven by our vision to make a difference in the world by making a meaningful impact on people's health.


Salary: $80,000 - $110,000 per year



Job Description:


We are seeking an experienced Pharmaceutical Quality Control Specialist to join our team. The successful candidate will be responsible for ensuring the quality of our pharmaceutical products through testing procedures and management processes.


Key Responsibilities:



  • Perform testing procedures and ensure data integrity and GMP compliance
  • Be responsible for method transfer/validation and equipment acquisition/qualification according to pharmacopeia and global regulations
  • Prepare protocols, execute testing, and generate reports accordingly
  • Investigate lab OOS/OOT and ensure logical and rational results using scientific tools
  • Perform regular checks and updates on procedures based on defects and gap assessments
  • Roll out PSS-related activities as pillar and lab PDCA demands
  • Define safety stock and monitor lab reagent use, reference standards, calibrated glassware, and set best practices to balance cost, quality, and efficiency
  • Plan and organize outsource testing to ensure compliance with quality requirements and local authority requirements
  • Conduct lab consumables management, including defining right places vs SAP and managing safety stock to ensure lab business continuity
  • Responsible for analyst training and qualification


Requirements:



  • Bachelor's degree or above in analytical chemistry or pharmacy-related majors
  • 5+ years of pharmaceutical lab experience
  • Familiarity with pharmacopeia (e.g., Ch.P, EP, and USP etc.)
  • Familiarity with cGMP, EU GMP, FDA, and ICH regulations
  • Familiarity with computerized systems, lab instruments (HPLC, GC, etc.), and analytical techniques
  • Good coordination, communication skills, and good English skills
  • Good learning ability and result orientation, accuracy, etc.

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