[Japan] Shiga Quality Assurance Team Specialist

Santen is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with our footprint in over 60 countries, we are dedicated to delivering innovative treatments and digital solutions for eye health and addressing vision-related social issues for people around the world.

【Basic Mission】 While ensuring alignment with higher-level policies and strategies, the basic mission is to provide high-quality products to society through a pharmaceutical quality system based on scientific evidence, and to achieve the "Quality Policy" and "Quality Objectives" by planning and executing continuous improvements. Furthermore, in the assigned duties, the individual will collaborate with team managers and team members, demonstrate leadership toward problem-solving, and perform duties autonomously, thereby contributing to the optimization of team operations and the achievement of organizational goals.

＜Expected Roles＞

■ Possess advanced specialized knowledge and skills regarding assigned and related duties, exert influence within the organization even regarding complex issues, and perform duties autonomously toward problem-solving.

■ Under comprehensive instructions from superiors, identify problems and causes in one's own duties, and independently set tasks and formulate solutions to execute duties.

■ Involve superiors and obtain support from surroundings to make appropriate judgments and perform duties.

■ Provide appropriate advice and support to members of lower grades.

■ Promote continuous improvement within the assigned team and contribute to the fostering of a continuous improvement culture.

＜Main Duties＞

・Construction and maintenance of a pharmaceutical quality system that meets the Santen Quality Manual, cGMP, and relevant domestic and international regulatory requirements.

・Review of manufacturing records, preparation of Certificates of Analysis (CoA), and release determination from manufacturing sites.

・Management and supervision of GMP compliance and practice in pharmaceutical manufacturing (site patrols).

・Lifecycle management of GMP documents (Product Standard Files, Standard Operating Procedures (SOPs), etc.) and records based on ALCOA+.

・Maintenance and management of computerized systems in compliance with data integrity requirements.

・Leading or supporting investigations, impact assessments, and CAPA formulation for quality events (deviations, complaints, changes, CAPA, etc.).

・Effectiveness evaluation of CAPA.

・Management of non-conforming products.

・Management of raw material suppliers and external contractors.

・Construction and improvement of GMP training programs.

・Creation of training plans and execution according to the annual schedule.

・Creation of self-inspection plans and execution according to the annual schedule.

・Responding to internal/external GMP audits.

・Preparation of Product Quality Reviews.

・Monitoring of quality KPIs, promotion of continuous improvement, and reporting to management.

・Participation in and contribution to projects to achieve strategies and objectives of the production and quality departments.

Experience: Experience in Quality Assurance or Quality Control duties in the pharmaceutical industry (3 years or more preferred)

・Knowledge: Knowledge of GMP, ICH guidelines, FDA regulations, and other relevant regulations.

・Skills: Leadership skills, coaching and mentoring, communication skills, problem-solving abilities.

・Skills: English (intermediate level or higher preferred)

・Other: High ethical standards, attention to detail, teamwork spirit.

(Scope of changes in job content) All company business

(Scope of changes in work location) Head office and business offices/sales offices nationwide </body>