Freelance GMP Auditor / GMP監査員・コンサルタント（業務委託）

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

ProPharma is expanding its network of Japan-based freelance Good Manufacturing Practice (GMP) auditors to support pharmaceutical and biotechnology clients on individual assignments across Japan. We are interested in experienced lead auditors and capable co-auditors whose expertise can be matched to the technical scope of each project.

Assignments may involve pharmaceutical manufacturers, active pharmaceutical ingredient (API) facilities, contract manufacturing partners, sterile production sites, laboratories, clinical-supply providers or logistics partners. Work typically combines focused preparation, on-site or remote assessment, clear reporting and agreed follow-up. This is an ongoing consultant-network opportunity rather than a guaranteed, continuous engagement.

We welcome expertise in one or more areas below; applicants are not expected to cover all of them.

• Small-molecule APIs, chemical manufacturing, ICH Q7 and related supplier qualification.
• Sterile/aseptic drug-product manufacturing, cleanrooms, contamination control and EU GMP Annex 1; including ophthalmic, injectable or other specialised products.
• Biologics, monoclonal antibodies, biotechnology manufacturing, CDMO/CMO operations and technology-transfer-related quality systems.
• Drug-product manufacture, packaging, labelling, clinical-supply services and outsourced pharmaceutical operations.
• GMP/GDP interfaces: third-party logistics (3PL), warehousing, temperature-controlled storage, distribution and supply-chain quality.
• Quality control laboratories, microbiology, validation, facilities/utilities, computerized systems, data integrity and GMP quality management systems.

• →Plan and conduct risk-based GMP audits in line with the agreed client scope, applicable regulations and relevant procedures.
• →Review pre-audit documentation, prepare audit plans or checklists, and examine facilities, processes, records, deviations, CAPA and supplier controls.
• →Lead or participate in site interviews, facility walkthroughs, evidence review, daily debriefs and closing meetings.
• →Document well-supported observations, assess their significance and produce accurate, timely audit reports and recommendations.
• →Review responses or corrective and preventive action plans when included in the assignment, and work effectively with ProPharma’s audit coordination and technical-review teams.

• Substantial hands-on GMP experience in pharmaceutical/biotechnology quality, manufacturing or compliance, with direct participation in GMP audit execution (internal, supplier, third-party or equivalent).
• Ability to assess a clearly defined GMP scope, gather objective evidence, identify compliance gaps and communicate defensible findings.
• Sound working knowledge of Japanese GMP/PMDA expectations and the regulatory standards relevant to your own audit speciality.
• Native-level Japanese proficiency for technical interviews, documentation review and professional communication with Japanese sites.
• Based in Japan and able to travel to client sites within Japan for assignments agreed in advance; able to work independently and maintain confidentiality, impartiality and professional standards.

• Lead-auditor responsibilities, third-party vendor qualification and a documented recent audit log.
• Demonstrable experience with EU GMP Annex 1 and aseptic/sterile drug-product sites; or specialist API, biologics, CDMO, clinical-supply or 3PL/GDP audits.
• Relevant international frameworks such as ICH Q7, PIC/S GMP, EU GMP, US FDA 21 CFR Parts 210/211 and data-integrity expectations, as applicable.
• Professional English communication, particularly the ability to conduct cross-border discussions and draft or review English-language audit reports.
• Inspection readiness, PMDA/FDA/EMA-related assessments, supplier remediation, CAPA effectiveness assessment or technical consulting.

Engagements are offered on a case-by-case basis and may range from short on-site audits to assignments with additional preparation, document review, report writing and follow-up. Remote or hybrid components depend on the client and audit scope. Fees, hours, deliverables, travel arrangements and any reimbursable expenses are agreed separately for each engagement. Appointment remains subject to technical fit, availability, client approval and applicable contractor onboarding. There is no guaranteed volume of work.

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.

Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***