Senior Quality Assurance Associate

JL 6 - Sr. Associate, Quality Assurance

Drive awareness of the Quality System as a strategic platform for the business. Works in close collaboration with internal stakeholders and supports multiple projects with high standards of compliance to the regulatory and quality systems requirements.

Work with QA leadership to ensure that products comply with market authorization and GMP requirements and are received, stored, handled, released, distributed and transported according to regulatory requirements including but not limited to ISO 13485, EU-MDR (if applicable to the region/country), GDP and relevant local requirements. Review documentation including Quality Assurance Agreements and approve incoming batches of medicinal products and /or medical devices (as applicable per market) product returns and annual product quality reviews as required per local market.

Participate as needed in all activities required for an effective Quality Management System including but not limited to, self-inspections, supplier qualifications and monitoring, CAPA process, management review, change control, risk management, Quality Planning, key performance indicators and SOP compliance. 

Participate in audits of GxP suppliers, and self-inspection program, lead external audit preparation activities (as applicable) and contribute to external audits by Notified Bodies and Health Authorities as needed.

Perform non-conformance investigations and provide guidance as needed ensuring formal structured approach to root cause analysis and problem solving, ensuring adequate corrective actions and prevention plans are implemented.

Ensure that all GxP suppliers and distributors where applicable, are adequately qualified and monitored and processes are compliant with Alcon Quality requirements (e.g. warehouse, distribution, redress/relabeling)

Raise awareness of QA risks as appropriate to QA management of affiliate and contribute to appropriate and timely escalation of quality events to management.  Participate in the execution of market actions as needed.

Support initiatives to drive performance and ensure alignment with established KPIs, resulting in consistent goal attainment and operational excellence.

All associates must adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training. Associates are responsible for meeting their individual job requirements and contributing to the overall compliance of the organization. Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations.

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Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital status, disability, or any other reason.

Experience Level

Senior Level