Sr Associate Quality Assurance📣 إعلان

About Alcon and the Senior Associate Quality Assurance Role

Alcon is a global leader dedicated to enhancing sight and improving eye health worldwide. With a team of over 25,000 associates, Alcon is committed to innovation, progress, and swift action to impact global eye health. This full-time Sr Associate, Quality Assurance position is based in Riyadh, Saudi Arabia, and offers an opportunity to contribute to a company that fosters an inclusive culture and supports career growth.

Purpose of the Role

The Sr Associate, Quality Assurance plays a key role in maintaining and enhancing Alcon’s Quality Management System (QMS). This position ensures compliance with both global and local regulatory requirements. The role involves collaborating with cross-functional teams to support various quality operations, contributing directly to product quality, patient safety, and operational excellence.

Key Responsibilities: Quality Systems and Operations

• 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.

Vigilance Management and Continuous Improvement

• 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.

Required Experience

• A minimum of 5 to 10 years of experience in Quality Assurance or a related field.

Work Environment and Culture

Alcon is committed to fostering an inclusive culture where contributions are recognized and opportunities for career growth are provided. The company operates with a focus on fearless innovation and swift action to impact global eye health, making it a dynamic environment for professionals dedicated to quality and patient safety.