Mallinckrodt Pharmaceuticals

Job Title

医薬品質管理・試験担当者（神戸）

Requisition

JR000015014 医薬品質管理・試験担当者（神戸） (Open)

Location

Kobe, Japan

Additional Locations

Job Description Summary

• This position requires native Japanese language ability.

The Quality Control (QC) Analyst is responsible for conducting QC testing of pharmaceutical products at our facility located in Kobe, Hyogo Prefecture, Japan. This role ensures compliance with Good Manufacturing Practice (GMP) standards while consistently supporting both internal and external stakeholders to maintain the highest quality standards.

Job Description

Essential Functions

• Conduct routine testing for the release of raw materials, finished pharmaceutical products, and stability assessments.
• Prepare, review, and maintain documentation, including Standard Operating Procedures (SOPs), protocols, training modules, investigations, reports, and Quality Management System (QMS) documents (e.g., Out of Specification (OOS)/Out of Trend (OOT), Deviations, Change Control, Validation).
• Utilize expertise in chemistry, High-Performance Liquid Chromatography (HPLC), and Liquid Chromatography-Mass Spectrometry (LC/MS), with a willingness to learn and apply new analytical techniques as the laboratory advances.
• Adhere to established testing schedules for the facility and stability programs to ensure timely and accurate reporting.
• Perform daily laboratory operations to support efficient workflow and maintain compliance with industry standards.

Minimum Requirements

Education / Experience / Skills:

• Native-level proficiency in Japanese, both written and spoken.
• Minimum of 1 year of experience in a similar role.
• Preferably at least 1 year of experience working under current Good Manufacturing Practice (cGMP) regulations.
• Hands-on experience with High-Performance Liquid Chromatography (HPLC) is preferred.
• Self-motivated professionals with a strong work ethic.
• Excellent interpersonal and communication skills, including proficiency in verbal and written Japanese.
• Ability to work effectively in a collaborative team environment.
• Strong ability to identify, execute, and prioritize work tasks/projects, with sound judgment on when to escalate issues.
• Proven problem-solving, decision-making, and communication skills.
• Proficiency in business and technical software applications (e.g., Microsoft Word, Excel, PowerPoint).
• Highly organized, with the ability to plan, manage, and prioritize tasks effectively.
• Demonstrates high levels of integrity and trustworthiness.

Organizational Relationship/Scope:

The Quality Control (QC) Analyst reports directly to the Senior Manager, Kobe QC Grouop and is responsible for conducting testing and analysis within the QC function. The role requires close collaboration with Senior QC Analysts in the laboratory, as well as cross-functional coordination with Quality Assurance (QA) and Supply Chain teams within the Kobe facility to ensure compliance and operational efficiency.

Working Conditions:

This position primarily requires on-site work at the laboratory facility.

A flexible work schedule is available, with a standard working time of 7 hours and 50 minutes per day.

Core working hours are set from 10:00 to 15:00, ensuring operational alignment while accommodating flexibility in start and end times.

Disclaimer:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

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