Quality Specialist – Pharmaceutical Quality Assurance

About the role

The Quality Specialist will ensure that all pharmaceutical products meet the highest standards of safety, efficacy, and regulatory compliance. You will lead quality initiatives, support audits, and act as a key liaison during regulatory inspections.

Key responsibilities

• Maintain full compliance with Good Storage and Distribution Practices (GSDP) and all applicable regulations.
• Develop, implement, and continuously improve the Quality Management System (QMS).
• Manage quality events, including deviations, CAPA, change controls, and risk assessments.
• Conduct internal audits and support external audits and regulatory inspections.
• Serve as the primary contact during inspections, ensuring inspection readiness.
• Control quality documentation such as SOPs, policies, and records.
• Oversee supplier qualification, audits, and performance monitoring.
• Ensure proper storage, handling, and distribution conditions for product integrity.
• Review and release pharmaceutical products in line with approved procedures.
• Provide quality oversight for logistics and warehouse activities, adhering to GSDP and ISO standards.
• Manage customer complaints, investigations, and timely resolutions.
• Supervise temperature mapping, validation activities, and storage compliance.
• Monitor Quality KPIs, report findings, and drive corrective actions.
• Deliver training programs on quality standards and promote a strong quality culture.

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, regulatory requirements and ISO standards.
• Proven ability to manage audits, inspections, and quality system processes.
• High attention to detail with strong analytical and problem‑solving abilities.
• Excellent communication and interpersonal skills.
• Ability to work independently and collaboratively within a team.

Required skills

• Good Storage and Distribution Practices (GSDP)
• Quality Management System (QMS) implementation
• Corrective and Preventive Actions (CAPA)
• Change Control management
• Risk Assessment
• Internal and External Auditing
• Regulatory Inspection Management
• SOP and documentation control
• Supplier Qualification and monitoring
• Temperature Mapping and Validation
• KPI monitoring and reporting
• Training delivery on quality standards