Recruiting Information

Quality Assurance Specialist

Background of recruitment:
With an increase in new and developed products including Roche/Genentech ones and diversification of the supply chain, contract manufacturers, testing sites and suppliers, quality activities such as quality assurance, conclusion of quality agreement, CMO and supplier management, and audit have increased every year. For this reason, we are looking for flexible individuals who have a keen interest in GQP, QMS and GCTP/GMP/GDP.
Type of employment Full time employee
Description of work Ensuring compliance to GQP/QMS, GMP/GDP/GCTP for manufacturing, control and distribution operations performed in the sites.
  • Audit manufacturing and testing sites, and suppliers
  • Preparation and conclusion of quality agreement and liaison with manufacturing sites and suppliers
  • Perform complaint handling and support an effective complaints management process
  • Oversight of manufacturers of medical devices, Regenerative Medicine Products, biopharmaceuticals and small molecules, and suppliers thoroughout product life cycle: manage or support deviations, change control, and corrective and preventative action plans (CAPA) in manufacturing, testing sites and materials suppliers
  • Establish and maintain effective quality document management systems
  • Support the implementation and maintenance of Pharmaceutical Quality System in line with global standards
Required qualifications
  • Bachelor or master degree in science or engineering with experience in the pharmaceutical industry working.
  • Experience and background in manufacturing, materials management, QA/QC, auditing or preparation and conclusion of contract is highly desirable.
  • Good verbal communication and ability to keep excellent working relationships with peers and management.
  • Good level of written and spoken English
Place of business Ukima Research Laboratories (Kita Ward, Tokyo)
Hours Flex time system (core time: 11:30–13:30)

To be decided in accordance with our criteria.

Application method Please apply via the link below.
* We will not disclose any application to any third party.
* We will not use documents submitted by applicants for any purposes other than screening.
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