Global PV Inspection Lead — Readiness & Compliance (Remote)

Amaris Consulting | Part of Mantu

Eigenbrakel

Hybrid

EUR 85,000 - 110,000

Full time

5 days ago
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Benefits offered by this job

International team
Internal Academy with 250+ modules
Gym access & lunch vouchers
Language classes

Job summary

Amaris Consulting, part of Mantu, is seeking an experienced PV inspection specialist to drive inspection readiness and ensure compliance with GVP, GCP, and GLP. You will collaborate with PV, Regulatory, Clinical, and other teams across global sites and host inspections as needed.

The role emphasizes quality oversight of PV systems, audit readiness, and continuous process improvement, with opportunities to influence global PV practices within an international environment.

Qualifications

  • 5 to 8 years of experience in pharmacovigilance, GVP quality, or auditing.
  • Strong experience in inspection management.
  • Experience in pharmacovigilance inspections, ideally having hosted inspections.
  • Experience with global regulatory authorities: FDA, EMA, MHRA, etc.

Responsibilities

  • Drive inspection readiness activities for global PV inspections.
  • Collaborate with PV, Regulatory, Clinical, and other functions.
  • Review documentation to ensure compliance with GVP, GCP, GLP.
  • Support and host inspections (front/back room).
  • Provide quality oversight on PV systems and processes globally.
  • Prepare and support audit/inspection readiness and documentation review.
  • Facilitate communication during inspection management.
  • Contribute to continuous improvement of inspection management processes.

Skills

Inspection management
Pharmacovigilance
Regulatory knowledge
Auditing
Stakeholder management
English fluent
French a plus

Tools

PV systems
Quality management systems

Job description

Amaris Consulting, part of Mantu, is seeking an experienced PV inspection specialist to drive inspection readiness and ensure compliance with GVP, GCP, and GLP. You will collaborate with PV, Regulatory, Clinical, and other teams across global sites and host inspections as needed.

The role emphasizes quality oversight of PV systems, audit readiness, and continuous process improvement, with opportunities to influence global PV practices within an international environment.

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