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Job Description

Company Overview
Leading Global Company

Job Description
Senior GMP Quality Compliance Expert - Manager Level

Requirements
More than 5 years’ experience in a GMP, high paced manufacturing environment
 Experience in a regulated industry is required; cosmetic and/ or pharmaceutical experience a plus Experience with improving Quality Systems and process design is required
 Experience with authorizing and maintaining procedures and work instructions is required
 Knowledge of compliance, related to all applicable Quality Systems Standards national and international, is required Ability to build and deliver training modules
 Creative individual with excellent trouble shooting skills
 Strong oral and written communication skills with ability to appropriately communicate information to cross functional stakeholders
 Ability to work in a team setting and independently under minimal supervision
 Ability to work in fast paced environment supporting the quality assurance/quality control departments Proficiency in Microsoft Office Suite, Electronic QMS, e-training systems and SAP systems is preferred
 Education: Bachelor’s science degree or equivalent experience
 Language: Good command in Japanese and English, both written and spoken

Additional Job Information
Position Summary:
Compliance Specialist is responsible for implementing policies, procedures and standards at a site to ensure compliance with regulatory and corporate requirements. This includes management of GMP document control systems, development of annual product review reports, administration of the compliant program, supporting site audits and development & delivery of GMP trainings.
Key Responsibilities:
Policies, Procedures and Standards (40%)
Implement and enforce policies, procedures and standards
Conduct internal site audits, document audit results and ensure site audit preparedness
Maintain knowledge and understanding of applicable GMP regulations, regulatory agency guidelines, industry association guidelines and good practices
Manage complaint program and monitoring for trends, coordinate requirements of investigation from site when required
Manage annual product review reporting which includes compiling data for reports and completion of each report (adhering to schedule for APR Execution)
Document Control Systems (30%)
Site owner and subject matter expert for the management of GMP documentation, change control and CAPA systems
Manage the document change control processes that involve the receipt, maintenance, approval, distribution, maintenance of files and storage of documents to include, but not limited to: batch records, standard operating procedures, protocols, deviations, investigations and standard forms.
Training/Coaching (30%)
Develop and implement a standardized training process that complies with all regulatory/corporate requirements (GMP focus) by working with site functional leads, Quality CoE Training & Capabilities Manager, Corporate QA, and training peers to develop processes, tools and templates to deliver a standardized approach
Establish training curriculum and assignments based on assigned functions in collaboration with site leadership and Quality CoE Training & Capabilities Manager
Develop and deliver site level GMP training for new employees and re-fresher trainings as required Develop, maintain and report appropriate training metrics