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Full-time
Posted 19d ago
~40 hrs/week
Responsibilities
Lead production activities for the manufacturing and redressing of reagents while ensuring compliance with ISO QMS and EHS standards. Manage production staff, coordinate with cross-functional departments, and drive continuous improvement projects.
Requirements
Requires experience in production leadership and manufacturing process protocols, including validation and evaluation. Must be proficient in managing ISO audits and implementing corrective and preventive actions (CAPA).
Full job description
Key Job Purpose:
Lead production activities for the manufacturing and redressing of reagents, collaborating closely with Sysmex personnel to achieve production and redressing targets while ensuring compliance with the ISO Quality Management System (QMS) and all applicable environmental, health, and safety (EHS) standards.
1.
Production Leadership
Guide and assess performance of production staff in accordance with Production department goals
Maintain department staff capabilities by recruitment and development of employees.
Act as delegate to Manager, Production where needed.
2.
Production Processes
Completion of all associated production and redressing activities with good documentation and manufacturing practice.
Planning and preparing detailed daily job assignments of production and redressing personnel.
Handle manufacturing process protocols such as validation in I, O, PQ & evaluation when required.
3.
Production Administration
Liaise with Maintenance, Quality Control, Warehouse and Production Management as needed to facilitate production and redressing operations.
Establish and support a work environment of continuous improvement.
Ensure compliance with environmental, safety and quality policies and system.
Lead implementation of continuous improvement and capability enhancement projects.
4
ISO QMS & EMS
Support continuous process monitoring and reporting of process performance.
Facilitate, revise, or establish on process work instruction.
Lead investigation and resolution of customer complaints and implement Corrective Actions – Preventive Actions (CAPA) from all findings and provide response to QM/QA.
Support departmental ISO audits by internal/external auditor.
Sysmex Corporation is a global leader in in vitro diagnostics. Since its foundation in 1968, Sysmex has focused on diagnostics as the core of its business, and today, it supports the health of people in over 190 countries and regions worldwide. Sysmex continues to innovate in diagnostics, and to collaboratively create unique values in the areas of personalized medicine and novel treatments, under its long-term vision of "Together for a better healthcare journey." Through its unique technology, solutions, and co-creation with various partners, Sysmex delivers new value and addresses the universal desire of people to live longer and healthier lives.
Read our Social Media Policy here: https://www.sysmex.co.jp/en/policy.html
Sysmex Corporation is a global leader in in vitro diagnostics. Since its foundation in 1968, Sysmex has focused on diagnostics as the core of its business, and today, it supports the health of people in over 190 countries and regions worldwide. Sysmex continues to innovate in diagnostics, and to collaboratively create unique values in the areas of personalized medicine and novel treatments, under its long-term vision of "Together for a better healthcare journey." Through its unique technology, solutions, and co-creation with various partners, Sysmex delivers new value and addresses the universal desire of people to live longer and healthier lives.
Read our Social Media Policy here: https://www.sysmex.co.jp/en/policy.html