Quality Operations Specialist (F&A)

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募集要項

会社概要

同社は化粧品、医薬部外品の製造、販売、輸出入を行っています。

業務内容

Position Summary

• To identify, design and lead/execute QE projects through the use of statistical tools and other problem-solving methodologies. This position will drive improvement initiatives locally to ensure that processes are capable of meeting the quality standards and expectations of the Companies and its customers.
• To provide technical support to QA and other departments. This position must have technical credibility within the organization as well as with customers and suppliers. This position assures compliance to regulatory requirements and focuses on the consumer expectations.

Job Description & Major Duties:Issues Resolution/Continuous Improvement (60%):

• Identify and review deviations, determine root cause, and develop CAPAs in collaboration with Quality, Operations staff and suppliers to address product quality issues and GMP related activities
• Certify CAPA completion and effectiveness
• Escalate critical issues to Quality/Operations leadership as required
• Investigate critical customer and consumer complaints
• Disposition out-of-spec materials, as directed
• Monitor progress against improvement initiatives identified by Quality Engineers, CI and ME

Document Review & Auditing (30%):

• Conduct documentation reviews in the plant (production, importation and compounding as applicable) for compliance with existing procedures and instructions, and verify the effectiveness of procedures and instructions versus the requirements and needs
• Perform final (for importation yearly) review of executed batch and filling records and disposition product
• Initiate, revise and review controlled documentation including procedures, investigations, deviations, and reports.
• Participate in routine GMP audits in the plant

Training/Coaching (10%)

• Provide training and coaching to Quality and Operations, on topics such as SOP, GMP and root cause analysis

応募条件

Requirement:

• Bachelor’s science degree or equivalent experience
• Minimum 5 years of quality experience in a manufacturing environment preferred
• Japanese (Native / Fluent), English (Business / Conversational) – both written & spoken
• Experience in Fast Paced Consumer Goods manufacturing environment a plus (Cosmetic, Food, or Pharma)
• Ability to interpret and assess operational compliance against Good Manufacturing Practice Regulations (FDA, KFDA, HC, ISO22716)
• Ability to execute and coach teams in root cause problem solving and associated Corrective and Preventive Actions (CAPA)
• Ability to identify and drive process improvement opportunities by partnering with cross functional stakeholders
• Ability to execute, summarize and manage process audits in the manufacturing areas
• Effective oral and written communication skills and ability to appropriately communicate information to cross functional stakeholders and suppliers
• Knowledge and ability to execute statistical sampling, AQL/ANSI interpretation, and read/interpret specifications, drawings and compounding/assembly instructions
• Ability to utilize standard tools and equipment (such as scale, fill weight, cap torque, viscometer, pH meter, pull force, seal burst, and other relevant equipment)
• Ability to review SOP’s, GMP reports, batch records and investigations
• Proficiency in Microsoft Office Suite, Electronic QMS, and SAP systems is preferred

給与

550 - 850 万円

勤務地

その他