Pharmaceutical Quality GCP, MHRA Mock Inspector

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

📋 Description

• Perform mock inspections in line with Good Clinical Practice (GCP), encompassing planning, agenda setting, on-site investigations, coaching, and report preparation.

• Assess Sponsors, Contract Research Organizations (CROs), and investigator sites.

• Create detailed inspection reports that outline findings.

• Deliver written reports in English following inspections.

• Collaborate effectively with clients to uphold quality standards.

⛳️ Requirements

• Applicants must reside in the United Kingdom.

• Registration with the Advarra consultant network is essential for consideration.

• A minimum of 10 years of experience in Quality Assurance and/or Good Clinical Practice (GCP) is required.

• At least 5 years of experience in conducting Good Clinical Practice (GCP) inspections is necessary.

• Proven experience working with the MHRA (Medicines and Healthcare products Regulatory Agency).

• Demonstrated capability in leading, developing, and executing investigation activities.

• Proficiency in English communication at a B2 level, both verbal and written.

• A Bachelor's degree is required.

• Excellent interpersonal skills and the ability to engage effectively with clients.

• Strong analytical, problem-solving, communication, and report-writing capabilities.

• Ability to collaborate across departments and engage with both internal and external stakeholders.

🏝️ Benefits

• An inclusive and collaborative workplace culture.

• Appreciation for diverse perspectives.

• A chance to have a significant impact on clinical research.

• Access to consultant network opportunities for projects based in the UK.