Quality Assurance Specialist Spain
hace 1 día
At ES16 Alcon Healthcare S.A. Company, 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 our team.
As a Quality Assurance Specialist Spain, you will execute quality-related activities at the Alcon Spain commercial affiliate, ensuring compliance with applicable regulatory standards and global requirements. The position has accountability to develop and execute strategies for the Quality oversight of the affiliate and to lead the development and execution of Quality Assurance plans in Spain. This position is based in Spain. In this role, a typical day will include:
- Performing the duties as Responsible Person for Medical Device and Medicinal products in Spain in accordance with local legislation.
- Ensuring that processes and procedures needed for an effective Quality System are established, implemented and maintained, including but not limited to, self-inspections, supplier qualifications, CAPA process, Quality Planning and SOP preparation.
- Gathering, maintaining and reporting key quality indicators for the country/cluster, and promote process improvements using lean methodology, self-inspections and CAPA/deviations system.
- Ensuring that products are received, stored, handled, distributed and transported according to regulatory requirements for the affiliate, by engaging with external Logistics Providers and ensuring that all GxP suppliers are adequately qualified and monitored.
- Promoting a strong Quality Culture and awareness of regulatory and customer requirements throughout the affiliate.
- Driving awareness of the Quality System as a strategic platform for the business.
- Engaging affiliate personnel through development of adequate GxP training and effective communication.
- Leading and providing guidance to non-conformance investigations ensuring formal structured approach to root cause analysis and problem solving, ensuring adequate corrective actions and prevention plans be implemented.
- Conducting audit preparation activities, facilitate, support and close out external audits by Health Authorities and Notified bodies, ensuring all corporate requirements are met and robust CAPAs implemented.
- Ensuring continuous Quality System Compliance by adherence to established and evolving Alcon and regulatory requirements.
WE ARE SEEKING:
- Bachelor's degree in pharmacy, with the ability to practice as a pharmacist in Spain.
- Preferred master's degree in Pharmaceutical Industry, Quality Management, or an MBA.
- Fluent in Spanish, with an upper-intermediate level of English. Knowledge of Catalan is a plus.
- Minimum of 2-5 years in Quality Assurance or a related role within the pharmaceutical or medical device industry, including distribution, commercial organizations, or manufacturing.
- Regulatory Knowledge: Proficient in relevant standards such as EU drug GDP, ISO 13485:2016, and EU MDR.
- Supplier Management: Experience in managing third-party suppliers.
- Direct experience with Health Authorities and notified bodies is highly valued.
- Preferred Commercial QA Experience: Quality Assurance experience in a commercial business setting.
- Experience in supply chain management or finished product distribution is highly appreciated.
- Certified Quality Auditor is nice to have
HOW YOU CAN THRIVE AT ALCON:
- Competitive salary
- Comprehensive benefits package
- Training and continuous development; Be part of a high performing leader in ophthalmology company with a lot of opportunities to further develop your professional career.
- International exposure
- Open, friendly and collaborative culture; Work in a challenging environment with an outstanding team that will support him to achieve goals and performance.
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