■External Supply Quality Assurance Manager
Ensure that all aspects of the handling, manufacturing, and distribution of pharmaceutical products are in compliance with the Quality Manual, the effective Quality Agreement that they meet relevant cGMP regulatory requirements and are conducted according to local SOPs. Ensure that a valid QA agreement defined in line with the requirements of the Global template is in place which clearly defines cGMP roles and responsibilities between the company and External Supplier, as well as Product details and requirements.Request, review and process GMP documentation as defined by the Quality Agreement and SOPs. Manage the quality aspects of the relationship in accordance with the effective Quality Agreement, as well as SOPs, such as APQR and Trending, CAPA follow-up, Quality Risk Assessment, Change Control, etc. Perform the required periodic review and make recommendations for amendments to the agreement based on identified needs and issues.Responsible for coordinating and ensuring that Quality auditing of External suppliers is carried out according to the Quality Manual.Escalate any issues or instances of instability per the company`s escalation policy, and initiate any market action that is required.
・ About 5 years experience in the pharmaceutical industry, with direct experience with Pharmaceutical/Biopharmaceutical/API products. Experience in QA Operations, production, QC and/or other relevant operational areas, but must include minimally 3 years in QA.
・ Thorough knowledge of cGMP requirements
・ Strong understanding of regulatory requirements for commercial products
・ Strong understanding of risk assessment and risk management fundamentals/tools
・ Strong Technical understanding of pharmaceutical processes
・ Team and consensus builder, with definitive and authoritative decision making ability
・ Excellent oral and written Japanese
・ Fluent in speaking / writing in English