Quality Specialist

About the role

The Quality Specialist will ensure that all pharmaceutical products are stored, handled, and distributed in compliance with Good Storage and Distribution Practices (GSDP) and relevant regulatory requirements. This role drives continuous improvement of the Quality Management System (QMS) and supports audit readiness across the organization.

Key responsibilities

• Maintain full compliance with GSDP, GDP and all applicable regulations.
• Develop, implement and continuously improve the QMS.
• Manage quality events such as deviations, CAPA, change controls and risk assessments.
• Conduct internal audits and support external audits and regulatory inspections.
• Act as primary contact during regulatory inspections, ensuring inspection readiness.
• Control quality documentation, including SOPs, policies and records.
• Oversee supplier qualification, audits and performance monitoring.
• Ensure proper storage, handling and distribution conditions to preserve product integrity.
• Review and release pharmaceutical products in line with approved procedures.
• Provide quality oversight for logistics, warehouse activities and temperature‑controlled operations.
• Manage customer complaints, investigations and timely resolutions.
• Lead temperature mapping, validation activities and storage compliance.
• Monitor Quality KPIs, report findings and drive corrective actions.
• Deliver training programs on quality standards.
• Collaborate with cross‑functional teams to meet health‑authority regulations.
• Promote a strong quality culture and continuous improvement initiatives.

Required profile

• Bachelor’s degree in Pharmacy.
• 4–6 years of Quality Assurance experience in the pharmaceutical industry.
• Hands‑on experience with external audits and regulatory inspections.
• Strong knowledge of GDP/GSDP guidelines, QMS, ISO standards and regulatory requirements.
• Excellent analytical, problem‑solving and communication skills.
• Ability to work independently and as part of a team.

Required skills

• Good Storage and Distribution Practices (GSDP)
• Good Distribution Practice (GDP)
• Quality Management System (QMS)
• CAPA management
• Change control
• Risk assessment
• Internal and external audits
• Regulatory inspections
• Temperature mapping
• Validation activities
• ISO standards compliance