[Tokyo/Shizuoka/Ibaraki] QA for Drug Development and New Product Launch

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Job details

Company overview

Our client is a global pharmaceutical company with its own distribution channels around the world.

Responsibilities

• Contribute to development projects by ensuring the quality of investigational drugs used in clinical trials conducted globally and complying with regulations such as GMP.
• Promotion of quality assurance operations such as management of investigational drugs, investigational drug substances and new product manufacturing contractors, change management in the development phase, implementation of quality audits, shipment of investigational drugs by appropriate product quality management, etc.
• Building and collaborating with joint development partners
• Improvement of global quality assurance system for developed products, continuous improvement, promotion of new regulation compliance
• Promote regulatory inspection response and inspection preparation in cooperation with related departments such as laboratories, manufacturing contractors, and supply chains so that early application and launch of new products can meet and respond to regulatory requirements globally.
• Participate in the global working team within Quality Assurance and Quality Technology to solve quality assurance issues and improve and improve the quality assurance system.
• Initial development phase Quality assurance work at product manufacturing plants such as regenerative medicine

Requirements

• BA or Higher degree in related field of study
• English Level: Business
• Japanese Level: Native
• Those who can actively and enthusiastically work on change, appropriately cooperate and cooperate with related organizations inside and outside the company and lead the business.
• Those who have knowledge about quality assurance work for developed products or work related to launching new products
• Those who have the level of English proficiency required for business execution and can communicate globally (TOEIC score 800 points or higher or equivalent English proficiency)
• Person who has participated in or led a global project
• Person who has experience in work related to bio-related products such as antibodies
• Person who has experience of new modality related work such as regenerative medicine related products and gene therapy related products
• Persons who have knowledge and experience regarding CMC-related products such as manufacturing processes / test method development for pharmaceuticals and new modality products, as well as investigational drugs.
• Those who can or are willing to lead the business through communication with foreigners
• Those who can think for themselves, propose countermeasures, and act on their own without fear of failure

Salary

7 - 12 million yen

Location

Tokyo