QA Compliance and Metrics Analyst
•Preparation, assembly, critical review and submission for approval of Field Action Assessments, regulatory reporting to ensure agreed and statutory target dates are met.
- Preparation, assembly, critical review and submission for approval of Field Action Assessments, regulatory reporting (Field Alert Reports, regulatory responses and follow up reports) to ensure agreed and statutory target dates are met.
- Must be able to work within a multiple disciplinary across multiple time zones to accomplish completion of activities.
- Review of new regulatory standards / guidelines and determination of impact of changes on Alcon systems and procedures.
- Must be able to perform and review site gap assessments associated with Novartis Quality module /directive implementation.
- Prepare divisional summaries of findings as needed.
- Prepare gap assessment tools used for dissemination of Rapid Alert information.
- Prepare divisional summaries for Rapid Alert assessments.
- Develop compliance communication tools to be distributed to manufacturing sites.
- Support risk assessment remediation activities, as needed.
- Support the management of market withdrawal activities to include reconciliation of units, documentation of destruction, reporting updates to regulatory agencies and maintaining documentation in an audit ready state.
- Must be able to manage all aspects of assigned projects including planning, execution, documentation, scheduling, regulatory compliance with a high degree of independence.
- Perform monthly, quarterly and annual trending /reporting as required.
- Participate in establishment of budget and budget presentations.
- Thorough knowledge of standard quality concepts, practices and techniques.
- Requires sound written and oral communication skills.
- Develops solutions to problems of moderate scope and complexity.
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 [email protected] and let us know the nature of your request and your contact information
alrpo 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. Minimum requirements •Bachelor’s degree or equivalent years of directly related experience
- 3 years directly related experience
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