Quality Assurance Specialist

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Job Objective

The Quality Assurance professional is responsible for maintaining, monitoring, and continually enhancing the affiliate's Quality Management System (QMS) to ensure compliance with Roche Pharmaceutical Quality System requirements, applicable GxP regulations, local regulatory standards, and relevant ISO requirements. The role supports the consistent supply of safe, high-quality products while promoting continuous improvement across quality processes.

Key Responsibilities

• Conduct periodic management reviews of the Quality Management System (QMS) by monitoring performance indicators and evaluating compliance with established quality standards.

• Implement and maintain quality management processes in accordance with ISO standards and other applicable regulatory requirements by reviewing global Standard Operating Procedures (SOPs), assessing their local impact, and adapting them where necessary.

• Identify quality-related deviations or non-conformities and ensure timely investigation and resolution through established quality management processes.

• Manage changes affecting processes, personnel, or systems by assessing potential impacts, coordinating implementation activities, and communicating changes to relevant stakeholders.

• Oversee the Corrective and Preventive Action (CAPA) process by identifying root causes of quality issues, implementing appropriate corrective and preventive measures, and evaluating their effectiveness to ensure continuous improvement.

Qualifications and Requirements

• Bachelor's degree in Pharmacy, Medicine, Pharmaceutical Chemistry, Pharmaceutical Technology, Biology, or another related scientific discipline.

• Three to five years of relevant experience in Quality Assurance, Regulatory Affairs, or Quality Management within the pharmaceutical or medical device industry.

• Demonstrated commitment to maintaining compliance with organizational policies, regulatory requirements, and Standard Operating Procedures (SOPs).

• Good understanding of current pharmaceutical regulatory frameworks and applicable industry regulations.

• Practical knowledge of Quality Assurance principles and Quality Management Systems within a pharmaceutical environment.

• Familiarity with ISO standards and their application in quality management and continuous improvement initiatives.

Application

Go to Roche Kenya on careers.roche.com to apply