Consultant for Medicine Dossier Assessment and GMP/GSDP Auditing (Remote)

Job summary

This role involves joining a roster of pre-qualified consultants to conduct technical assessments of medicinal product dossiers and perform audits against Good Manufacturing Practices (GMP) and Good Storage and Distribution Practices (GSDP). The position is remote and aims to support quality assurance in the supply of medicines, particularly in low- and middle-income countries.

Qualifications

• Advanced degree (Master’s or higher) in Pharmacy, Pharmaceutical Sciences, or a related field with a focus on Chemistry, Manufacturing, and Controls (CMC).
• Minimum of 8 years of relevant experience in pharmaceutical regulation, including product assessment at the national level; regional or global experience is a plus.
• Strong understanding of pharmaceutical markets and regulatory science, with excellent technical writing skills in English (knowledge of additional UN languages is advantageous).

Responsibilities

• Conduct technical assessments of medicinal product applications, including administrative, quality, and safety/efficacy evaluations.
• Prepare detailed assessment reports with queries, conclusions, and recommendations.
• Plan and execute GMP audits for various manufacturing sites and GSDP audits for warehousing and distribution facilities.
• Document findings, classify observations, and follow up on corrective actions post-audit.

Skills

• Proven regulatory inspection experience in GMP for both sterile and non-sterile products.
• Strong documentation and reporting skills.
• Ability to work collaboratively across time zones, particularly aligned with Central European Time (CET).

Education

• Advanced university degree in a relevant field.

Tools

• Familiarity with WHO GMP guidelines and Codex Alimentarius standards.