ProPharma
Life Sciences Consulting
Auditor
Neural analysis suggests this role is
optimal for Senior candidates.
“Auditor at ProPharma. Skills: GCP audits, GVP audits, GMP audits, Pharmacovigilance audits. Plan audits. Conduct audits”
Industry & Context.
Assess compliance risk; Assess materiality of findings
Support onsite audit work
What They're Looking For.
Must Have
Native level Japanese language capability, Business level English, Based in Japan, Proven experience conducting audits
Nice to Have
Experience working as an independent consultant, Experience supporting international clients, Experience conducting audits in both Japanese and English, Experience with onsite audit delivery in Japan, Experience reviewing audit logs, Ability to support short term assignments
What You'll Do.
Review operational processes
Review quality systems
Review vendor oversight
Review compliance controls
Identify audit findings
Assess compliance risk
Prepare audit reports
Support follow up activities
Review root cause analysis
Review CAPA responses
Review closeout actions
Engage professionally with clients
Engage professionally with auditees
Engage professionally with stakeholders
Support onsite audit activity
How You'll Work.
Team & Collaboration
Engage with clients; Engage with auditees; Engage with stakeholders
Communication Scope
Written communication; Audit documentation; Client communication; Report preparation
Full Job Description
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. **LOCATION** Japan, Remote **ENGAGEMENT TYPE** Freelance, contractor, project based **FUNCTION** Quality, Audit, Life Sciences Consulting **OVERVIEW** ProPharma is seeking experienced freelance life sciences auditors based in Japan to support upcoming client audit activity on a project based contractor basis. We are interested in speaking with senior quality, compliance, clinical research, pharmacovigilance, PMS, GVP, GPSP, and GMP professionals who have hands on audit experience in Japan. This opportunity may suit candidates with experience in one or more of the following areas: GCP audits, including investigator site audits, CRO audits, vendor audits, sponsor process audits, or clinical quality systems GVP, GPSP, PMS, pharmacovigilance, safety, case processing, call center, or post marketing related audits GMP audits, including small molecule API, manufacturing, supplier, vendor, or quality system audits The work may include onsite, remote, or hybrid audit activity depending on the assignment, client requirements, and auditor availability. This is not a permanent employee position. Assignments will be offered on a freelance contractor basis, typically linked to specific client audit needs. **KEY RESPONSIBILITIES** * Plan, conduct, and report audits in line with a
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