Quality Specialist – Pharmaceutical Quality Assurance

About the role

This Quality Specialist position covers quality assurance in the pharmaceutical industry, focusing on compliance with Good Storage and Distribution Practices (GSDP), regulatory requirements and the quality management system. The role also oversees supplier quality, temperature mapping, validation and customer complaint handling.

Key responsibilities

• Ensure full compliance with GSDP and all applicable regulatory requirements.
• Develop, implement and continuously improve the quality management system (QMS).
• Manage quality events such as deviations, CAPA, change controls and risk assessments.
• Conduct internal audits and take part in external audits and regulatory inspections; act as the main contact during inspections and keep the site ready.
• Maintain and control quality documentation, including SOPs, policies and records.
• Oversee supplier qualification, audits and ongoing performance monitoring.
• Ensure proper storage, handling and distribution conditions, and oversee logistics and warehouse activities in line with GSDP and ISO standards.
• Review and release pharmaceutical products according to approved procedures.
• Handle customer complaints, investigate them and ensure timely resolution.
• Oversee temperature mapping and validation activities.
• Monitor quality KPIs, report on them and implement corrective actions.
• Deliver quality-related training and collaborate with cross-functional teams to meet health authority regulations.

Required profile

• Bachelor's degree in Pharmacy.
• 4-6 years of experience in quality assurance within the pharmaceutical industry.
• Proven hands-on experience in external audits and regulatory inspections.
• Demonstrated experience managing audits, inspections and quality system processes.
• Strong attention to detail, analytical and problem-solving abilities, and excellent communication skills.

Required skills

• Strong knowledge of GDP/GSDP guidelines, QMS and regulatory requirements.
• Familiarity with ISO standards.
• Ability to work independently and in a team.