Quality Control Manager - Shizuoka

• Achieve QC Goals & Objectives
  
• Develop and maintain Quality Management Systems in accordance with the Japanese and international regulatory requirements.
  
• Create and maintains procedures in the quality control section. Monitors compliance with the requirements of approved procedures.
  
• Approve or reject test methods and specifications of raw materials, packaging materials, intermediate products and finished products.
  
• Ensure that the testing of raw materials, packaging materials, intermediate products, and finished products are completed properly in accordance with the defined procedures.
  
• Ensure trend of test results are monitored
  
• Ensure that testing of environmental monitoring is performed properly.
  
• Ensure that testing for process or cleaning validations is performed properly.
  
• Ensure that the stability monitoring of finished products are performed properly.
  
• Review quality control records.
  
• Ensure that the maintenance and calibration program of equipment is done.
  
• Ensure that the laboratory is properly maintained (For example; document, glassware, chemicals, facilities and equipment).
  
• Ensure that the reference and retained samples are retained properly.
  
• Ensures that reference and working standards are maintained properly.
  
• Ensures that QC records are maintained properly.
  
• Ensure all the QC staff are trained and qualified.
  
• Oversee the outsourced activities at external laboratories.
  
• Ensure that investigation for complaints, OOSs, or deviations are performed properly.
  
• Ensure that actions for observations made in the internal audit, internal inspection, customer audits, and HA inspections are taken properly.
  
• Ensure that adequate data and information are provided to QA for preparing PQR reports.
  

Requirements

• Minimum BSc in Chemistry, Biology, or Pharmacology
  
• At least 5 years experience in QC of Pharmaceutical or Food industry
  
• In-depth understanding of regulations such as GMP, PIC/S GMP, ICH Q series, IPEC-PQG, GMP, ISO 9001, and/or ISO 17025
  
• In-depth understanding of compendium such as Japanese Pharmacopoeia, Japanese Pharmaceutical Excipients, or other countries’ pharmacopoeia
  
• In-depth understanding of analytical technique and methodologies
  
• In-depth understanding of Data Integrity
  
• Excellent numerical skills and understanding of data analysis/statistical methods
  
• Good attention to details and result-driven approach
  
• Excellent organizational and leadership abilities
  
• ​Good English communication skills