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2 weeks ago
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.
Job Summary- This position is responsible for the Quality compliance to ensure site is compliant to ISO 13485, MDSAP, EU MDR, Alcon Standards and Policies, and regulatory requirement.
Job Responsibilities- System Admin role for Trackwise Ace system on troubleshooting and user access management.- Trend, analyze and monitor key performance indicators, suggest improvements, and escalate to supervisor/management as necessary- Identify improvement opportunities and lead/support the implementation activities to improve performance and efficiency.- Meet quality objectives set by management & comply to Alcon, QMS and Safety requirements.- Coordinate activities and compliance to all applicable standards (e.g. ISO 13485, MDSAP) and regulatory requirements (e.g. EUMDR).- Perform Site's investigation (NCR, SAR, OOS, Complaints, etc) and Site's WI/SOP/Gap Assessment/Impact Assessment.- Identify, anticipate, investigate, and drive resolution on quality compliance issues and communications.- Coordinate/Manage Management Review.- Consolidate monthly data and prepare monthly summary report for site quality metrics reporting into Global Platform.- Assess change control for regulatory impact and quality representative for life cycle of product labeling and artworks.- Perform training for topics related to GMP/Date Integrity/Compliance.- Support, perform and/or lead internal audits, supplier audits and external/regulatory audits, including updating and maintenance of system related to audits.- Work with cross-functional teams to resolve operational quality issues- Performs any other duties as assigned by Supervisor according to business needs.
Requirement:
- Min Diploma in any science related courses- With 5-7 years experiences in Pharma or medical device industry
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