メディカル・バイオ - メディカルGQP・GMP・品質保証・品質管理
メディカル・バイオ - 品質保証

Execute internal audits (schedule, issue agenda, prepare, conduct audit, issue report)
Evaluate responses to internal audits

Facilitate and/or support external GMP audits and inspections (Health Authority, Customer). Including:
Inspection Readiness (audit preparation, schedule and manage mock inspections, SME coaching)
Partner with Quality to manage inspections (host and/or coordinate front room and back room, daily inspection summaries)
Review site response and associated CAPA for Health Authority inspections.
Provide input to daily inspection summaries, as needed.

Provide Compliance Subject Matter Expertise (SME) for site personnel, Quality Systems and/or projects. As needed, review complaints and field actions.
Represent Regulatory Compliance at Site Management Reviews, CAPA Review Boards, Escalations, Platform Compliance meetings, etc.
Partner with site for execution of proactive compliance scans.
Partner with site and segment personnel (e.g. Regulatory Affairs, Operations, Product Quality Management, etc.) to proactively identify risks and drive compliance improvement across the site.

Ensure timely and accurate reporting of compliance metrics.
Lead the Inspection Readiness Governance meetings.
Coordinate compliance training for the site.
Connect with external groups (e.g. Japan Manufacturers Association etc.) to benchmark industry standards.
As needed, co-authors, review, and revise compliance procedures.
As needed, review (not approve) significant manufacturing and laboratory investigations, confirmed complaints and S1/S2 Field Actions.

■休日：完全週休二日制, 土, 日, 祝日, GW, 年末年始

Bachelor’s degree in science or related field is required.
Minimum of five (5) years of experience in GMP-regulated industry and at least one (1) year of regulatory compliance experience is required.
Strong knowledge of global GMP regulations is required.
Strong analytical skills. Ability to clearly articulate issues.
Must have excellent communication skills, able to quickly build credibility within the Quality and Compliance community.
Delivers on commitment timelines and has high sense of urgency.
Experience preparing for inspections, managing inspections and/or supporting inspections.
QA/RA certification is preferred.
Experience performing internal or external audits is strongly preferred.
Experience in change management and project management.
Ability to communicate in both Japanese and English is strongly preferred.

■職種未経験者：不可