[한국 애보트] Sr QA Specialist 채용

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Sr QA Specialist를 모집 합니다.

JOB SUMMARY:

• Responsible for Quality Management system and to be 100% compliance with Corporate, Divisional and Korea regulations.

RESPONSIBILITIES:

• Execution of Product Shiphold, Field Safety Corrective Actions as per instructions from Regional or Corporate office.
• Provision of training to employees on quality related documents and policies
• Support and be accountable for external, internal and supplier audit in Abbott Medical Korea and the follow-up remediation plan.
• Preparation of data for management review.
• Identifies quality system problems, provides recommendations and resolutions.
• Manages the document control for all procedures and quality records
• Ensures all the Procedures are in place and the appropriate personnel have been trained on them.
• Interacts on a periodic frequency with Supply Chain, Technical Service and Education function on all quality related matters.
• Provides support to ensure that product labeling activities meets local and corporate/OUS quality & regulatory requirements
• Ensures that any changes to the Corporate Quality Manual and the OUS Quality Procedures are interpreted and implemented with the local Country manual and procedures where applicable.
• Manage the change control process to meet amendment to local regulatory compliance requirements.
• Prepare and  maintain KGMP Certifications and applicable Quality related certification in the region.
• Be involved in the Risk Management and conduct CAPA process
• Post Market Surveiliance/Complaint Handling
• Vigilance reporting to MFDS and follow up actions.
• KGMP certification and related all maintenance activities.

QUALIFICATIONS:

• Minimum of Bachelor’s degree. Equivalent education/work experience will be considered.
• Minimum of 4 years experiences as a QA in a Commercial Quality environment.
• Computer proficiency in Word, Excel and PowerPoint.
• Strong interpersonal skills, with the ability to build and maintain relationships.
• Effective time management - well organized, able to set and reset priorities
• Strong oral and written communication skills.
• Detail and deadline oriented.
• Conversant in both written and spoken English.
• Demonstrates a highly positive attitude concerning risk, change and unexpected challenges.
• Tendency to be friendly, cooperative, agreeable. To be a team person. Promotes the benefits of teamwork and cooperation. Is usually willing to share resources and information.

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https://www.jobs.abbott/us/en/job/31150181/Sr-QA-Specialist

Sr QA Specialist in Korea - Seoul | Quality at Abbott