Pharmaceutical Quality GCP EMA Mock Inspector – Consulting

Posted 4 days ago

This is a fully remote position, open to applicants in United Kingdom.

πŸ“‹ Description

β€’ Perform mock inspections in accordance with Good Clinical Practice (GCP), which includes planning, setting agendas, conducting physical assessments, providing coaching, and writing reports.

β€’ Assess Sponsors, Contract Research Organizations (CROs), and investigator sites.

β€’ Create detailed inspection reports that outline findings.

β€’ Deliver written inspection reports in English.

β€’ Collaborate effectively with clients to uphold quality standards.

β€’ Become a member of Advarra's consultant network for projects based in the EU.


⛳️ Requirements

β€’ At least 10 years of experience in Quality Assurance and/or Good Clinical Practice (GCP).

β€’ A minimum of 5 years of experience in GCP inspections.

β€’ Proven work experience with any European Health Authority.

β€’ Demonstrated ability to lead, develop, and execute investigation activities.

β€’ Proficiency in English communication at a B2 level, both verbal and written.

β€’ A Bachelor's degree is required.

β€’ Excellent interpersonal skills and ability to engage with clients.

β€’ Strong analytical, problem-solving, communication, and report-writing abilities.

β€’ Capacity to work collaboratively across various departments and interact with both internal and external stakeholders.

β€’ Registration is necessary for consideration unless you are already part of the consultant network.


🏝️ Benefits

β€’ An inclusive and collaborative work environment.

β€’ A commitment to respecting diverse perspectives.

β€’ The chance to make a significant impact in advancing clinical research.

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