General Electric Quality Assurance Manager - Japan in Minato, Japan
Role Summary:To manage and drive the QA systems and responsible for engaging to ensure compliance with current regulations (GQP ministry ordinance) with regards to the area of responsibility and specialization.
Essential Responsibilities:- Responsible for coordination of the certification of finished product batches to the market as required under local law and regulations
Engaging QA process under, e.g., Product Release, Complaint Handling, Investigations, CAPA, Warehouse Operations and/or 3PLs, APR/PQR, Stability Data Review, Validation, Change Control Management, Training, Distribution, etc.
Engaging the preparation and execution of Quality Management Reviews at the site
Engaging quality evaluation of warehouse operations, manufacturing sites, and external laboratories
Provide support to routine activities, projects, development and training relevant to area of expertise
Support continuous improvement activities regarding areas of responsibility
Engaging assessment regulatory impact on product and manufacturing processes.
Analyze & communicate proposed, new or changing requirements & devise strategies for their implementation, ensuring business goals are met. Includes liaison with other GE functions, industry bodies or regulators as required
Identify, assess and manage regulatory risk proactively and provide senior management with key data to help drive decisions
Maintain quality procedures up to date and reflective of regulatory requirements
Engaging site inspections, preparing audits observations response as necessary
Own compliance assessment and remediation plans while influencing execution, communications and training for Quality matters
Qualifications/Requirements:1. B.S. Degree in business or technical field
5 years experiences in medical device, pharmaceutical industry
Ability to work independently in fast-paced environment with little supervision.
Ability to adapt to constant change and influence positive change effectively
Team-oriented and responsive to customer needs
Quality-focused, attentive to detail and results-oriented
Ability to communicate effectively in Japanese and basic level of English (both written and oral)
Desired Characteristics:1. Pharmacist
Experiences with CA/PA systems (GE electronic QA system)
Experiences applying regulations (GMP, Good Distribution Practices)
QC testing experience for sterile products
Technical transfer experience for QC test or manufacturing process for sterile products
About Us:GE (NYSE:GE) drives the world forward by tackling its biggest challenges. By combining world-class engineering with software and analytics, GE helps the world work more efficiently, reliably, and safely. GE people are global, diverse and dedicated, operating with the highest integrity and passion to fulfill GE’s mission and deliver for our customers. www.ge.comAdditional Locations:Japan;Tokyo;