Country Quality Compliance Associate

Job description

Job Description

•Assist with the implementation of compliant processes within the Country organizations that ensure on-going compliance of all Country organizations with applicable regulatory requirements (i.e. GxP, ISO, Vigilance).
•The Country Quality Compliance Associate will actively engage with Country QA teams to assist with CAPA closure, collect data regarding audit observations, provide training to the affiliate teams on basic QA requirements, provide guidance for the maintenance and continuous improvement of the Quality Management System and maintain a collaborative relationship with the broader Corporate QA group.
•Provide support for regulatory inspection/audit (GMP, GDP, ISO, Vigilance) of Country Sites including assistance with preparation and follow-up in the Countries.
•Assist with preparation and review of responses for Health Authority, Notified Body and Division inspections and audits.
•Monitor CAPA closure, including execution of closure in AQWA and Trackwise systems.
•Assist with implementation, improvement and maintenance of of key quality systems within the CSCQ group and the Country QA community.
•Identify areas of opportunity to improve within the Country Quality organization and escalate to management.
•Assist with timely execution of deliverables of the CSCQ Quality Plan.
•Monitor the Country QA plans and ensure updates are submitted on schedule.
•Ensure metrics are collected and reviewed for the Country Quality scorecard and Quality Risk Assessment.
•Review the metrics and report on any actions required or recommended.
•Provide assistance for the escalation process, FAA process and Recalls
•Assist with implementation of adequate training within countries for all GXP activities by engaging in training activities for new hires and ongoing training initiatives.
•Prepare periodic reports for management
•Assist with implementation of the Quality Manual and multi-site procedures at the country level.

Alcon is an Equal Opportunity Employer and participates in E-Verify. As part of the Novartis Group of Companies, Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to and let us know the nature of your request and your contact information

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EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

Desired profile

Minimum requirements

•Bachelor's degree in Life Sciences, Pharmacy, or Engineering or equivalent combination of education and relevant experience.
•Fluency in English (oral and written)
•2 years relevant experience.