Quality Systems & Compliance Specialist

About the role

GM Pharmaceuticals is seeking a Quality Systems & Compliance Specialist to join its Tbilisi team. The role focuses on maintaining high‑quality standards across manufacturing and distribution processes, ensuring compliance with international pharmaceutical regulations.

Key responsibilities

• Develop and maintain Standard Operating Procedures (SOPs) and other quality‑related documentation.
• Participate in planning and implementing quality improvement projects.
• Contribute to the development and standardisation of Quality Risk Management (QRM) methodologies.
• Coordinate, manage, and document the transportation of medicinal products in line with quality requirements.
• Prepare and manage Quality Agreements with transportation service providers.
• Qualify, approve, and monitor distribution and transportation service providers.
• Oversee validation and qualification activities, managing timelines and implementation.
• Ensure timely completion of actions from approved changes and manage change control processes.
• Review supply‑chain traceability reports and evaluate effectiveness of implemented changes.

Required profile

• University degree in Pharmacy; a Master’s degree is preferred.
• Experience in a GMP‑compliant pharmaceutical manufacturing environment or Quality Management System role.
• Knowledge of international pharmaceutical standards such as EU GMP, EU GDP, WHO, ICH, ISO, and USP.
• Familiarity with local and international regulatory requirements for manufacturing and distribution.

Required skills

• Proficiency in Georgian, English, and Russian.
• Advanced proficiency in MS Office.
• Knowledge of EU GMP, EU GDP, WHO, ICH, ISO, and USP standards.

What we offer

• Stable employment in an international pharmaceutical company.
• Professional and career development opportunities.
• Competitive and growing compensation.
• Health insurance.