QA Professional providing oversight for projects in Koriyama factory. Ensure compliance with GxP regulations and high-quality standards in pharmaceutical manufacturing.
Responsibilities
Providing QA oversight and support for projects in Koriyama factory in Japan to ensure timely delivery with the right quality.
Participating in project and validation activities to resolve quality-related issues.
Performing quality spot checks and approving validation documentation to ensure the highest quality level.
Reviewing and approving complex change control requests, SOPs, trend reports, and validation-related documents.
Preparing annual product reviews and facilitating validation and other complex internal trainings.
Acting as a coach during audits and inspections, and ensuring compliance with regulations and corporate/local SOPs.
Providing proactive guidance to departments on quality-related activities and ensuring that current Novo Nordisk procedures and health authority requirements are reflected in quality decisions.
Requirements
Minimum 5 years’ QA experience, or minimum 7 years’ experience in QC/production or related roles (healthcare/pharmaceutical industry preferred), with a strong quality mindset and solid understanding of QA responsibilities.
Expert knowledge of quality management systems and cGMP production processes, with deep understanding of validation in pharmaceutical manufacturing preferred.
Ability to make autonomous, high‑level decisions on complex quality issues and to perform effectively with minimal supervision.
Strong cross‑functional leadership skills to drive process and team activities and to support others’ ideas and actions.
Native-level Japanese and business-level English communication skills, both written and oral.
PCB Suppliers Quality Engineer responsible for managing quality control and ensuring supplier compliance in PCB manufacturing processes. Collaborating with suppliers and internal teams for product quality improvement.
QA Analyst at Starr & Associates ensuring quality in custom - built technology solutions through functional and automated testing. Collaborating with engineers and analysts to validate requirements and deliver solutions.
Mechanical Construction Quality Assurance Inspection Professional providing on - site quality assurance and compliance monitoring for construction of a weapons storage facility. Join a veteran - owned small business delivering facility management to federal agencies.
Quality Control Technician ensuring fire alarm and safety systems meet quality standards at Johnson Controls. Collaborating with teams to maintain high safety and compliance.
Associate Director responsible for pharmacovigilance quality assurance audits and compliance. Leading audit programs ensuring adherence to regulations and supporting teams in various projects.
Senior Engineer managing supplier quality processes and improvement within ZF's initiatives in India. Collaborating with global teams to enhance compliance and performance in supplier networking.
Supplier Quality Engineer managing supplier quality for casting projects within ZF's operations in China. Supporting projects and ensuring compliance with quality standards across the region.
Quality Engineer at ZF involved in quality assurance and improvement processes. Collaborating internally and with customers to meet quality standards and drive continuous improvement.
Lead QA to oversee comprehensive testing strategies across multiple phases at RBC Capital Markets. Drive manual and automated testing initiatives ensuring product quality throughout delivery.
Senior Supplier Quality Engineer at EnerSys providing technical leadership in supplier quality. Overseeing compliance and continuous improvement in supplier performance and product quality.