PET QA Facilitator - Foreign pharmaceutical company

勤務地 Osaka, Japan
職種 正社員
給与 ¥8000000.00 - ¥12000000.00 per annum
Sub-specialization 品質管理 / 品質保証,
お問合せ Taizo Murabe
参照 JO-2003-438232
about Taizo Murabe

Job Description:

As the PET QA Facilitator, you will be responsible for ensuring the quality of licensed and clinical products manufactured at Maihara site.

The details are;

  • Responsible for ensuring the quality of licensed products manufactured at Maihara site.
  • Approves Deviations, Customer complaints, CAPAs, and GMP records.
  • Interprets and implements quality policies, manages quality systems and assists in facilitating regulatory compliance inspections.
  • Communicates company goals, safety practices, and deadlines to team. Motivates team members, provides guidance and leadership, assesses performance and help with development of direct reports.
  • Responsible for hiring and training, and to keep management updated on team performance.
  • Communicates concerns and policies among management and team members.
  • Ability to provide constructive feedback to staff.
  • Responsible for staff supervision and development including scheduling, recruiting and performance management.
  • Ability to develop staff through feedback and coaching and set mid and short-term priorities.
  • Builds and motivates teams.

Minimum Requirements :

  • BS or MS degree
  • 10+ years in a biotech/pharmaceutical industry with Bachelors
  • 5+ years of experience in biotech/pharmaceutical Quality
  • Advanced knowledge of GMP requirements, quality systems, and pharmaceutical manufacturing/packaging technologies.
  • Demonstrated management skills; ability to influence and engage direct and indirect reports and peers.
  • Strong written, oral, interpersonal, and presentation skills and the ability to effectively interface with all levels of management and staff.