Head of QC - For Japan Yamagata Site

It is QC Head based in Yamagata site, Japan. We are aiming to search a qualified candidate with proficiency of both English and Japanese, also could accept to work in Japan for long-term period. 

Basic Purpose of the Job: 

• Establish the Group's target and priority measures based on the policy of the Quality Operation Dept.
• Conduct quality evaluations of raw materials, bulk products, packaging materials, and finished products directly related to production, and carry out practical operations to maintain and manage quality levels.
• Plan, execute, and evaluate various requested tests, including process monitoring, validation, internal and external requested tests, and tests related to complaint investigations.
• Align and collaborate with related departments inside and outside of the plant to improve quality and solve problems on quality-related matters.
• Develop BPE activities related to the group to achieve operational optimization and develop human resources based on strategies of Human Pharma Supply Japan and the plant.

Job Responsibilities: 

• Establish the Group's target and priority measures based on policy and BSC in the Dept. Establish CapEx plan for 5 years. Secure enough resource to achieve target and establish resource planning.
• Assess and coordinate the issues and problems related to quality control with relevant departments and affiliates in order to find out appropriate solutions.  Exchange necessary information with BI Global Quality and overseas BI manufacturing sites on quality control related matters.
• Maintain the technical expertise required for quality control operations.
• Prepare and revise various test methods and related Standard Operating Procedures (SOPs) as needed. Manage and coordinate the progress of incoming inspection and stability testing, and evaluate and report the test results.
• Investigate the current status of the group and provide information to the Head of Quality Assurance. Propose measures to maintain the optimal quality evaluation system within the plant.
• Establish policy and guideline related to the working environment. Comply with such policy and guideline. 
• Develop Group's organization and resource.

Job Requirements:

• Bachelor's degree or equivalent ability and experience with major in Chemistry, Agriculture, or Pharmaceutical Sciences.
• More than 5 years' work experience in QC function as leader role from pharmaceutical or GMP required industries. 
• Knowledge of laws and regulations (Pharmaceutical and Medical Device Act, GMP, GMP-related notification, Japanese Pharmacopeia), quality control and quality assurance, pharmaceutical and physical chemistry (analytical chemistry, organic chemistry, statistics). 
• Basic knowledge of pharmaceutical production and products, accounting (financial accounting)
• Mature people leader with good labour planning and management of a big-size team