At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.
As a RA/QA Specialist you will be responsible for the implementation and maintenance of the defined regulatory strategy and the Quality management system under direct supervision of the QA/RA manager.
In this role, a typical day will include:
- Develops and maintain documents in QA /RA department that are clear, concise, and complete to facilitate reviews/approvals.
- Completion of assigned activities in accordance with Alcon’s Global Quality management system including but not limited to, self inspections, supplier qualifications, CAPA process and SOP compliance.
- Ensure local work instructions, where needed, are compliant with the Global Quality System Procedures (QSPs) and local quality procedures and adequate training assignments in place.
- Manage the release of products to the local market following relevant authorization from QA/RA Head
- Manage the local deviations process, ensuring adequate quality investigations and root cause determination.
- Participate in audits of GxP suppliers upon completion of External Auditor Certification and self inspection program upon completion of Internal Auditor Qualification, and contribute to external audits by Notified bodies and Health Authorities as needed.
- Manage assigned Change Controls in compliance with Alcon’s internal procedures and in accordance with Alcon’s global GxP Change Control procedure
- Act as the site training administrator in Alcon’s GxP Document and Training management tool Veeva Quality docs. Actives include management of document lifecycle for local documents, maintenance of training curricula / learner roles, monitoring, follow-up and reporting of training compliance.
- Monitoring and reporting of metrics related to the effective implementation of the Alcon Hellas training program.
- Ensure that all activities are recorded in accordance with good documentation practices and data integrity principles.
- Act as local subject matter expert and administer for Veeva Vault (Quality and RIM) including both document control and training.
- Provides support as needed for non-project related "regulatory excellence" activities.
- Ensures compliance with global and local regulatory requirements and adherence to internal policies and processes.
WHAT YOU’LL BRING TO ALCON:
Bachelor in Health Science studies, Biology, Chemistry, Pharmacy or similar field and advanced degree in Pharmaceutical studies, Medical devices
2 -4 years’ experience in work in Quality, Regulatory in other pharma or med tech companies
The ability to fluently read, write, understand and communicate in English
IT literacy in quality -regulatory systems
Preferred PHARMD - Licensed Pharmacist or any authorization from Ministry or HAs as responsible person in pharma industry
HOW YOU CAN THRIVE AT ALCON:
- Manage your own workload and schedule while hitting your set targets
- Collaborate with teammates to share best practices and learnings as work evolves
- See your career like never before with focused growth and development opportunities
Alcon Careers
See your impact at alcon.com/careers
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