QA Specialist

Company Overview
Global Pharmaceutical company

Job Description
・ Performs a wide variety of activities to ensure compliance with Good Quality Practices (GQP) and Good
Manufacturing Practices (GMP) and Good Distribution Practices(GDP).
・ Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met.
・ Maintains routine programs and processes to ensure high quality products and compliance with current
GQP/GMP/GDP
・ Reviews manufacturing, environmental monitoring and quality control data for in-process and finished
products.
・ Works directly with operating entities to ensure that inspections, statistical process control analyses and
audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
・ May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA)
recommendations related to manufactured products.
・ Normally receives very little instruction on routine work, general instructions on new assignments.

Requirements
・Demonstrates working knowledge of quality assurance systems, methods and procedures.
・Demonstrates thorough knowledge of GQP/GMP/GDP, and the interface with other functions like manufacturing, distribution and maintenance.
・Demonstrates audit and investigation skills, and report writing skills.
・Demonstrates strong verbal, technical writing and interpersonal skills.
・Demonstrates proficiency in Microsoft Office applications.
・Excellent Japanese and English general communication skills
・Knowledge of six sigma, LEAN and root cause analysis tools used for identifying and correcting deviations is preferred.

Additional Job Information
・Performs a wide variety of activities to ensure compliance with Good Quality Practices (GQP) and Good Manufacturing Practices (GMP) and Good Distribution Practices(GDP).
・Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met.
・Maintains routine programs and processes to ensure high quality products and compliance with current GQP/GMP/GDP
・Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products.
・Works directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
・May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
・Normally receives very little instruction on routine work, general instructions on new assignments.

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