Senior GCP Auditor | Inspections & Compliance | Remote

Ergomed; Polska; Sur place; PLN 180 000 - 240 000; Plein temps

Résumé du poste

Ergomed Group seeks experienced professionals to lead and coordinate GCP audits across sponsor and investigator sites, ensuring compliance with international and national GCP guidelines. You will plan, perform and report audits while supporting QA projects for client companies in the pharma/biotech sector.

The role requires up to 40% travel and the ability to conduct remote audits, with a strong foundation in GCP legislation and regulatory expectations.

Qualifications

• Experience conducting and leading internal and external GCP audits for a variety of stakeholders.
• Experience auditing service providers (e.g., full-service CRO, biostatistics, data management, phase I).
• Experience coordinating and managing inspection preparation activities for GCP process inspections at sponsor and investigator sites.
• Expert knowledge of national and international GCP legislation and guidelines.

Responsabilités

• Planning, preparation, conduct, reporting and follow up of various types of GCP audits.
• Executing audits based on a comprehensive understanding of regulatory requirements and GCP.
• Performing GCP quality assurance projects on behalf of client companies in the pharmaceutical/biotechnology industry.
• Coordinating and managing inspection preparation activities for GCP process inspections being conducted at sponsor and investigator sites.
• Conducting GCP mock inspections to Competent Authority standards is advantageous.
• Possesses up to 40% travel and ability to conduct remote audits.

Connaissances

GCP auditing

Regulatory knowledge

Project coordination

Travel readiness

Formation

BSc in Life Science

Description du poste

Ergomed Group seeks experienced professionals to lead and coordinate GCP audits across sponsor and investigator sites, ensuring compliance with international and national GCP guidelines. You will plan, perform and report audits while supporting QA projects for client companies in the pharma/biotech sector.

The role requires up to 40% travel and the ability to conduct remote audits, with a strong foundation in GCP legislation and regulatory expectations.