Quality Specialist – GxP Compliance (Bulgaria)

About the role

Er‑Kim is dedicated to ensuring no patient is left behind by providing access to innovative treatments across Central and Eastern Europe, the Mediterranean and Turkey. We are seeking a highly skilled Quality Specialist to oversee the company’s quality management processes and ensure full compliance with applicable standards and regulations. Based in Bulgaria, the successful candidate will work closely with internal teams and external partners to manage quality risks, develop and implement quality policies, and promote continuous improvement across all operations.

Key responsibilities

• Ensure all processes and procedures comply with GxP requirements.
• Monitor compliance with EU GxP guidelines and local regulations.
• Maintain awareness of updates to GxP regulations and implement changes as required.
• Participate in the development, implementation, and maintenance of the Quality Management System (QMS).
• Conduct regular audits of suppliers, service providers, and internal processes.
• Manage deviation reports, root‑cause analyses, and corrective and preventive actions (CAPA).
• Maintain and review GxP‑related documentation, including SOPs, training records and distribution records.
• Support supplier qualification processes and conduct risk assessments of suppliers and logistics partners.
• Provide GxP training to relevant personnel and ensure training programs are up‑to‑date.
• Investigate quality complaints related to distribution, manage product recalls and monitor temperature and environmental conditions during storage and transportation.
• Prepare for and participate in regulatory inspections and audits, address findings and produce regular quality performance reports.

Required profile

• Bachelor’s degree in Pharmacy or a related field.
• Minimum 2–3 years of experience in a quality/production role within the pharmaceutical industry.
• Strong understanding of GxP guidelines and related regulations.
• Familiarity with QMS, risk assessment and audit processes.
• Excellent organizational and communication skills, attention to detail and strong problem‑solving abilities.
• Upper‑Intermediate English language proficiency.

Required skills

• GxP compliance knowledge
• Quality Management System (QMS) implementation
• CAPA management
• Audit and supplier qualification
• Risk assessment
• Temperature and environmental monitoring