Senior/Advanced Project QA Professional

【求人No NJB2361383】
As a QA Professional you will play a key role in ensuring compliance with GxP regulations and maintaining the highest quality standards. Your responsibilities will include:

・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.

【Your skills qualifications】
We are looking for a dedicated and experienced QA professional who can bring the following qualifications to the role:

・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.