16863 Quality Compliance Lead
・Support Quality Assurance Supervisor for the product release to market by the proper evaluation for production control and quality control.
・Plan and execute the CAPAs for quality improvements and deviations by analyzing the information related to the product quality.
・Execute following tasks appropriately: Evaluate and confirm the changes the manufacturing processes and the test methods; Evaluate and handle the deviations during manufacturing; At product recall, prepare and file the reports to the authority and records/documents related; Appropriately manage to fulfil the requirements of Pharmaceutical & Medical Device Act. and other related regulations.
・Manage not to occur discrepancies between the contents in the approved file (site information, manufacturing processes, testing items and other necessary information) and the actual manufacturing site. Create of FMA application and maintain it.
・Create of GMP/GCTP inspection application and response to PMDA queries.
・Coordinate GMP/GCTP on-site Inspection by Health Authority.
・Generate labels for commercial product in accordance with Pharmaceutical & Medical Device Act.
・Build and maintain a close relationship of trust with global quality, and build and maintain processes aligned with the global quality management system.
・Share knowledge and provide guidance to the members.
・More than 10 years pharmaceutical industry with more than 5 years in a quality
control and/or quality assurance experience.
＜Key Competency Requirements＞
・Knowledge of PMD Act., GQP/GMP/GCTP ministerial ordinances, and related regulations.
・Basic knowledge of DS/DP manufacturing, packaging operation, quality control testing and Japanese Pharmacopoeia.
・Knowledge of accreditation/renew of accreditation for foreign manufacturer, regulatory application for periodical GMP/GCTP compliance inspection etc.
・Communication skill for achieving good relationship with authorities and connected departments.
・Strong leadership skill to perform cross functional tasks.
・Logical thinking to make regulatory strategy.
・Managing and supervising skill for appropriate manufacturing and quality control of the manufacturing sites (API site, Formulation site, etc.) listed in approved files.
・Capabilities of analyzing the management results of manufacturing sites, make instructions for improvement if necessary.
・Skill to negotiate with PMDA officer on regulatory application and inquires
・Communication skills in English via email and at meetings with overseas in charge person.