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Job Function: Quality
Job Sub Function: Supplier Quality
Job Category: Professional
Location: Shizuoka, Japan
Position Summary
The employee is responsible for implementation, improvement and harmonization of laboratory quality systems in accordance with GMP/GCTP and J&J quality guidelines.
Regulatory Compliance Responsibilities
Lab operations must be compliant with the following laws and regulations (but not limited to):
•GMP/GCTP
•Narcotics and Psychotropics Control Law
•Official compendium such as Japanese Pharmacopeia, etc.
•Pharmaceutical and Medical Device Act (PMD Act)
•Laws and regulations on Chemical Substances such as Poisonous and Deleterious Substances Control Law and the Hazardous Substances Control Law etc.
Major Job Duties and Responsibilities
•Responsible for implementation, improvement and harmonization of laboratory quality systems.
•Lead with transfer of analytical methods between other sites and Fuji and lead QC activities for the new product launch.
•Responsible for ensuring all laboratory systems comply with GMP/GCTP and J&J guidelines and quality standards, including support to regulatory filings and sub-system owner for laboratory systems.
•Perform activities in support of laboratory systems, e.g., stability program administration, analytical change control, Empower, training, etc.
•Leads and supports projects within laboratories aimed at improving on financial targets, efficiencies and productivities, achieving increasing agility and flow throughput, reducing cost, cycle time, inventory reduction, performance improvement and error reduction.
•Ensures required GMP/GCTP, EHS and role-related training required to work safely and in compliance with regulatory requirements and as defined by their training matrix. Proactively supports GMP/GCTP compliance, permanent audit readiness, identification of compliance risks and breaches.
•Any other duties as assigned by the Quality Control Manager or Lab Lead.
Job Requirements
Education and Experience
•Bachelor's degree or equivalent education in science, chemistry, biology, biotechnology, microbiology, or related fields.
•Over 3 years of work experience in the pharmaceutical industry.
•Experience in laboratory or laboratory systems-related activities under GMP-compliant conditions.
Knowledge, Qualification and Skills
•GMP/GCTP and Data integrity.
•Pharmaceutical regulations, standards, and guidelines.
•Experience in analytical testing, instrument analysis, and equipment management.
•Proficiency in documentation (e.g. SOP, WI, lab worksheet, and assessment).
•Ability to use basic PC software, including Microsoft Office and analytical software such as Empower (usage of software applications for data entry, data analysis, word processing, presentations, and calculations).
•Good communication skills in English (both written and verbal).
Core Competencies
•Credo value of integrity.
•Compliance with EHS rules and procedures.
•Report all incidents, accidents, and near missed events.
•Collaboration and teamwork.
Work format: On-site
Preferred Skills: Analytical Reasoning, Business Behavior, Compliance Management, Controls Compliance, Cross-Functional Collaboration, Execution Focus, ISO 9001, Issue Escalation, Performance Monitoring, Persistence and Tenacity, Quality Auditing, Quality Control (QC), Quality Standards, Quality Systems Documentation, Report Writing, Technologically Savvy, Vendor Selection
