Description

Job Summary

Thorough compliance with regulations and internal standards in the Vision Care Company as the Marketing Authorization Holder and Manufacturing License Holder, strives to ensure the quality and safety of products to be released to the market, and maintains and improves the quality management
system.

DUTIES & RESPONSIBILITIES

Establishes and maintains quality assurance programs, procedures, and controls.

       As a responsible engineer of the medical device manufacturing site, ensures that performance and quality of products conform to established company and regulatory standards.

       Assumes the responsibility of product quality release and contributes to smooth operation of logistics.

         Manages the qualification and validation for processes, which Quality Assurance (QA) is responsible and quality control support activities.

         Participates in risk management activities related to the product realization process in Japan.

         Supervises the development and control of local packaging and labeling materials and ensures their quality.

         Leads the preparation, execution and remediate actions related to the quality assurance activities of Haneda Distribution Center (HDC) resulted from internal and external audits.

         Leads/manages projects related to quality operations.

         Participates in the setting of own group objectives and measurement indicators, and also plans and executes actions based on Commercial Quality OGSMs.

        Contributes as the core team to carry out the recall operation without delay.

        Acts as advisor to subordinate supervisors or staff to help meet established schedules or resolve technical or operational problems.

        Handles/evaluates/approves nonconformities happened at HDC.

        Manages temporary employees.

       Submit and administer budget schedules.

Qualifications

EXPERIENCE & EDUCATION

University/bachelor’s degree or equivalent. Physics, chemistry, biology, engineering, informatics, metallurgy, electronics, mechanics, pharmacology, medicine, or dentistry is preferable

At least 8 years of GMP, GQP or QMS experience in the pharmaceutical, quasi-drug or medical device industry.

 REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES AND AFFILIATIONS

Understand and practice regulations related to medical devices, validation, and risk management methods.

Business English skills (Conversation, reading and writing) are preferred. Eventually, those who can make an effort to conduct business in English.

Business/Native level of Japanese ( Conversation, reading and writing)

General PC skills (Word (Word), Excel (Function), Power Point (Slide)) and Digital tool acumen

High communication skills and strong leadership.

Strong commitment to work and ability to execute with speed and flexibility