Sr Associate Quality Assurance📣 إعلان

About Alcon

Alcon is dedicated to enhancing sight and supporting global eye health. With over 25,000 associates worldwide, the company focuses on innovation and progress. Alcon fosters an inclusive culture, valuing contributions and offering career development opportunities to its employees, who collectively impact the lives of patients and customers.

The Role of Sr Associate, Quality Assurance

As a Sr Associate, Quality Assurance at Alcon in Riyadh, Saudi Arabia, you will be instrumental in maintaining and enhancing the company’s Quality Management System. This full-time role involves ensuring compliance with global and local regulatory requirements. You will collaborate with cross-functional teams to support quality operations, supplier oversight, audits, investigations, and continuous improvement initiatives, contributing to product quality, patient safety, and operational excellence. The position requires 5-10 years of relevant experience.

Key Responsibilities

• Drive awareness and effective implementation of the Quality Management System (QMS) across the business.
• Ensure compliance with applicable regulations and standards, including GMP, GDP, ISO 13485, EU-MDR (where applicable), and local regulatory requirements.
• Review and approve quality documentation, Quality Assurance Agreements, product returns, and Annual Product Quality Reviews.
• Support product handling, storage, distribution, and release activities in compliance with regulatory and quality requirements.
• Support Quality Management System activities, including CAPA, change control, risk management, management review, quality planning, KPI monitoring, and SOP compliance.
• Conduct non-conformance investigations and support root cause analysis and corrective/preventive action implementation.
• Raise awareness of quality risks and support timely escalation of quality events when needed.
• Participate in supplier audits, self-inspections, and supplier qualification activities.
• Support post-market surveillance activities and ensure compliance with applicable regulations.
• Collect, review, and evaluate post-market data from customers, distributors, healthcare providers, and other sources.
• Act as the primary liaison with SFDA for vigilance-related communications and requests.
• Coordinate responses to SFDA inquiries, requests for additional information, and inspection observations related to vigilance activities.
• Monitor changes to SFDA vigilance regulations, guidance documents, and reporting requirements.
• Support implementation of regulatory updates within the Quality Management System (QMS).
• Coordinate investigations of complaints and adverse events with internal stakeholders and manufacturers.
• Monitor complaint trends and identify potential safety signals requiring further evaluation.
• Partner with internal stakeholders to support multiple projects while maintaining high standards of quality and compliance.
• Support initiatives that drive operational excellence and achievement of quality KPIs.
• Contribute to continuous improvement programs that strengthen quality performance and business effectiveness.

Candidate Profile

• Strong attention to detail and commitment to quality and compliance.
• A proactive approach to identifying risks and implementing solutions.
• Excellent stakeholder management and communication skills.
• Ability to work effectively in a fast-paced and highly regulated environment.
• A continuous improvement mindset and passion for operational excellence.

Career Development

This role offers the opportunity to make a direct impact on customer satisfaction and patient outcomes within a global healthcare leader. You will join a collaborative team focused on continuous improvement and operational excellence, with avenues to develop expertise and grow your career in an environment that values innovation, learning, and professional development.