Quality Assurance Consultant

About the Role

PharmEng Technology is seeking a Quality Assurance Consultant to join their team in Riyadh, Saudi Arabia. This full-time role is responsible for the implementation, maintenance, and oversight of the Quality Management System (QMS) within local affiliates. The consultant will ensure compliance with regulatory requirements, quality standards, and company policies.

Key Responsibilities

• Implement, maintain, and oversee the QMS in local affiliates.
• Maintain the local Quality Manual and Site Master File.
• Manage quality risks, including identification, analysis, communication, control, and escalation.
• Coordinate complaint management, including reporting, local assessment, and investigation.
• Manage change controls, including QA assessment, review for implementation, and closure.
• Handle deviations for internal, external, and transport-related issues.
• Manage Corrective and Preventive Actions (CAPA) arising from deviations, audits, and self-inspections.
• Oversee authority inspections and self-inspections.
• Conduct local GxP surveillance and assessment.
• Perform Product Quality Reviews (PQR).
• Manage training, including maintaining the training matrix, training local staff, conducting annual GxP refresher training, and handling LMS assignments.
• Execute local product release (local QP), review transport performance, conduct goods receipt checks, and manage deviations.
• Oversee Good Distribution Practice (GDP) requirements for local warehousing and distribution.
• Qualify shipping lanes and review local transport performance for secondary distribution.
• Manage product returns, including QA evaluation against criteria and collaboration with distributors.
• Coordinate product recall management, including local execution, communication with customers and Health Authorities (HA), recall reconciliation, and local product destruction.
• Manage GxP suppliers, including identification, qualification, approval, annual compliance evaluation, audit planning, conduct, and CAPA approval/closure.
• Oversee local repackaging and relabeling, including change management, protocol, execution, QA review, and release.

Qualifications and Experience

• 5-10 years of relevant experience in Quality Assurance.
• Demonstrated experience with Quality Management Systems (QMS).
• Proficiency in managing quality risks, complaints, change controls, deviations, and CAPA processes.
• Experience with GxP surveillance, product quality reviews, and training management.

Required Skills

• Strong attention to detail and accuracy.
• Excellent organizational and time management skills.
• Effective leadership and team management abilities.
• Proactive and results-oriented mindset.

Work Type and Location

This is a full-time position based in Riyadh, Riyadh, Saudi Arabia. The salary for this role will be discussed during the interview process.