Alcon are one of Korea ‘Top Employer’s’ and are the market leader in eye care globally, helping people see better through advanced surgical and vision care products and if you want to help make a difference then please join us!
Major Accountabilities
- Support and maintain the processes and procedures needed for an effective Quality Management System, covering all necessary GxP, Quality regulations and standards, including but not limited to, self inspections, supplier qualifications, CAPA process and SOP compliance.
- Responsible for all incoming products are received, inspected, stored, handled, redressed, released, distributed, transported and destroyed according to labelled, regulatory and GxP requirement.
- Implement Alcon Quality System Procedures (QSPs, MSPs, FSPs) at local level and ensure local SOPs and/or work instructions are in place if needed, including adequate and timely training assignments.
- Ensure document management system is implemented properly and on time.
- Ensure continuous improvement through Change Controls and by management of local deviations through the identification, investigation, root cause determination, documentation, follow up and closure of Corrective Actions. Escalate as required.
- Ensure GxP suppliers are properly qualified, monitored and processes are compliant with Alcon Quality requirements (e.g. warehouse, distribution, redress/re-labelling).
- Plan, conduct and report audits required as part of the self-inspection program and ensure audits of GxP suppliers are performed as necessary. Prepare, facilitate and report on external Quality System audits by Notified bodies and Health Authorities as needed.
- Ensure that an adequate and effective Change Control process is in place.
- Manage complaints, recalls, counterfeits and product tampering according to the Alcon Corporate Quality Manual and Escalate as required.
- Gather and report Key Quality Indicators in accordance with Corporate QA requirements.
- Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that technical support on all quality related matters is provided to the country.
- Ensure that coordinated contact and collaboration is maintained with the Regulatory Authorities, the local partners (suppliers, third parties, licensees, and distributors) and other Alcon areas.
- Create and maintain local SOPs/forms related to medical device management in alignment with local requirement and Alcon QMS.
Qualification
- Education: University degree qualification or equivalent in Scientific or Engineering discipline
- Languages: Fluency in both written and spoken Korean and English
- Experience: Minimum: 2 years of experience in Quality environment in medical device or pharmaceutical business/ Commercial awareness of medical device market and/or pharmaceutical industry
ATTENTION: Current Alcon Employee/Contingent Worker
If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.
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Eligibility Requirements
No reason for disqualification on overseas business trip
Men are required or exempted from military service.
Information on returning employment documents
* All applicants, except those who pass the final round, will be able to claim the return of the submitted employment documents during the period between 14 and 180 days from the date on which employment is confirmed.
*In preparation for the applicant's request for return, we will keep the documents within 180 days after the announcement date of the final successful candidate, and the documents that have expired return period will be destroyed under the Personal Information Protection Act.
-If the application is submitted on the website or by e-mail, or if the applicant submits it voluntarily without our request, it shall not be returned in accordance with the proviso to Article 11 (1) of the Fairness of the Employment Procedure Act, and if the employment documents are destroyed due to natural disasters or other reasons not liable to us, it shall be deemed to have been returned.
*Applicants who wish to request the return of employment documents under the proviso to paragraph (1) submit a return request (Form 3 of the Enforcement Rules of the Act on the Fairness of Employment Procedures) by e-mail to the person in charge of employment and we send it to the designated address within 14 days from the date the submission is confirmed.