ABOUT ABBOTT :

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Established Pharmaceuticals

We are committed to bringing the benefits of our trusted medicines to more people in the world’s fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory.

Location : Ansan(근무지 : 안산)

Primary Job Function:

• Manage the development, establishment and implementation of all aspects of the quality assurance and quality control responsibilities for EPD Korea to ensure that products imported meet standards and specifications required by Abbott policies and governmental requirements.

Core Job Responsibilities:

Quality Management

• Develops/maintains the quality policies and practices for manufacturing and distribution operations within the context of corporate and divisional quality policies and governmental regulations.
• Formulate short-term and long-range quality objectives, plans and programs, working closely with divisional quality organizations.
• Arrange Quality Management Review with local executives and GM

Product batch release

• Manage the quality inspection and test activities to include incoming inspection tests on packaging materials, in-process tests, finished goods and imported products release tests to conformances to specifications
• Final approval for batch release

Change Control, Nonconformance(NC) and CAPA Management

• Participate in analysis of product performance problems and product nonconformance in conjunction with divisional quality.
• Conduct/approve Impact assessment, investigation, set up action plans, effectiveness check as per related procedures
• Maintain related records and track progress status

Complaint / Product Action / Product Hold Management

• Review and approve complaint records
• Communicate with stakeholders
• Arrange local product action committee and report to regional quality
• Establish for action plan with the committee and follow-up implementation
• Submission required documents to local health authority
• Manage product hold if any request from local or global

Internal audit and external inspection

• Perform periodic internal audit and full warehouse inspection to ensure that local quality system is in compliance with applicable quality standards and regulations.
• Participate internal audit as an auditor to a plan approved in advance.
• Organize inspections and appropriately respond inspectors
• Manage action plans for any observations identified by auditors after root cause investigation, and complete required actions and effectiveness check

Supplier Management

• Manage the auditing and approval of vendors to ensure maintenance of quality standards and specifications.
• Participate supplier audit as an auditor according to a plan approved in advance.

Document Control

• Prepare, implement and maintain appropriate quality and warehousing documents, records and files.
• Manage local procedures and product maser files
• Conduct impact assessment of local procedures when global or regional procedures are revised
• Approve Annual Product Quality Reports
• Approve validation and calibration records
• Approve records of facility control, shipping inspection, nonconforming products and returned products.

Training

• Provide appropriate quality system training for personnel engaged in quality related activities.
• Establish training matrix and annual training schedule
• Manage ISOtrain activities as a local training coordinator.

Others

• Effective supervision of his/her subordinates for successful execution of the job assigned.
• Effectively communicate with all level of staff and have a good working relationship with management and employees to promote teamwork.
• Perform other activities or special projects as assigned by management and/or instructed by director.
• Address/Support any regulatory submission to local health agency

Minimum Education required:

• Bachelor’s degree or equivalent in Pharmacy
• Pharmaceutical qualifications in an experienced quality system management discipline or equivalent would be desirable.
• Registered pharmacist is required. (약사 자격증 필수)

Minimum Experience/Knowledge required:

• More than 10 years’ experience working and managing a quality assurance in pharmaceutical company. (QA Specialist인 경우 경력 3년 이상)
• Previous experience should demonstrate the ability to perform quality control and quality assurance activities.
• Familiarity with the Pharmaceutical Law and related regulations.
• GMP knowledge
• A good understanding of written and verbal English is desired.

* Remark : 후보자의 경력에 따라 QA Specialist 또는 QA Manager로 채용*