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.
The Quality Assurance Manager is responsible for the management of the local Quality Management System (QMS) under limited supervision. The Quality Manager works closely with the Head of Quality, ensuring a high level of compliance with the requirements of EN ISO 13485, cGMP/cGDP and Alcon global procedures in the local affiliate.
In this role, a typical day will include:
1. Promote a strong Quality Culture throughout the affiliate. Drive awareness of the Quality System as a strategic platform for the business.
2. Deputize for the Head of Quality in his absence including duties as Deputy Quality Management Representative in accordance with ISO and other requirements.
3. Provide training on quality issues to the business unit and ensure the dissemination of quality knowledge throughout the organization.
4. Monitor and report on the performance of the quality management system, produce data and report on performance and measure it, against established standards.
5. Conduct internal quality audits to demonstrate the level of compliance of the affiliate.
6. Work with Head of Quality to ensure that processes and procedures, needed for an effective Quality System in are established, implemented, and maintained, including but not limited to, self-inspections, supplier qualifications, CAPA process, Quality Planning and SOP compliance.
7. Ensure that products are received, stored, handled, released, distributed, and transported according to labelled, regulatory and GxP requirements.
8. Ensure adequate use of Change Control at the affiliate.
9. Ensure that all GxP suppliers are adequately qualified and monitored and processes are compliant with Alcon Quality requirements (e.g. warehouse, distribution, redress/relabeling)
10. Participate in audits of GxP suppliers and lead external audit preparation activities and contribute to external audits by Notified Bodies and Health Authorities as needed.
11. Manage and provide guidance to non-conformance investigations ensuring formal structured approach to root cause analysis and problem solving, ensuring adequate corrective actions and prevention plans are implemented.
12. Escalate risks as appropriate to QA Head of affiliate and promote process improvements.
WHAT YOU’LL BRING TO ALCON:
- Education: • B. Pharm degree or Science Degree
- Languages: • Fluent English both spoken and written.
- Experience with Quality systems, ISO 13485 or ISO 9001 or other relevant experience with Quality in the pharmaceutical or medical device industry.
- Proven experience in Quality environment in medical devices
or pharmaceutical business
- Commercial awareness of the medical device market and/or pharmaceutical industry
- Knowledge of supply chain quality management and auditing.
- Knowledge of SAHPRA quality regulatory requirements.
- Computer literacy with standard software platforms
- Planning & organization
- High level of accuracy and attention to detail
- Teamwork & collaboration
- Integrity & initiative
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
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What We Do
Alcon helps people see brilliantly. As the global leader in eye care with a heritage spanning more than seven decades, we offer the broadest portfolio of products to enhance sight and improve people’s lives. Our Surgical and Vision Care products touch the lives of more than 260 million people in over 140 countries each year living with conditions like cataracts, glaucoma, retinal diseases and refractive errors. Our more than 20,000 associates are enhancing the quality of life through innovative products, partnerships with eye care professionals and programs that advance access to quality eye care.
