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Job Description

Computer System Validation Engineer

Philip Morris Korea Inc. is currently seeking talented, technical-savvy professionals to join in Quality team. As part of dynamic Quality team, you will have opportunity to ensure manufacturing process (including equipment, methods) and local computerized systems are appropriately qualified and validated while conducting review or related documentation and leading quality risk assessment and change management activities. OPPORTUNITIES • Manage the organization's site-specific CSV(Computer System Validation) process, procedures and shared practices, which includes the development, implementation, maintenance and training and ensuring that they are in accordance with the external requirements such as GAMP (Good Automated Manufacturing Practice) and the internal governing quality standards. • Provide technical support and guidance to internal and external customer to develop CSV-related documents such as specifications, as well as, execution of validation projects, including the reviewing and approving of the key set of validation documents to ensure compliance to internal process, procedures as well as external requirements. • Maintain that the systems are in a ready validated state by reviewing of the validated state periodically; involve in change control process and ensuring that performance assessment for the systems are completed timely. • Review and approve validation deviations of systems and provide assistance in identifying the root cause and to implement corrective action in a timely manner. • Interact with interdepartmental contacts on all validation-related activities such as deviation assessment, resolution and quality approval Implement and maintain the license management for facility. • Assist or interact with regulatory agencies as necessary and lead an internal and external audit in terms of CSV. Must be able to effectively present documentation associated with validation. • Maintain and improve PMK’s Data integrity with expertise. REQUIREMENTS • At least 3 years of experience in CSV field • Pharmaceutical, IT and consulting for CSV industries are preferred • Fluent level of written and spoken English and Korean • University graduate in Chemical Engineering , Computer Engineering or equivalent Terms of Employment • Contract Type : Permanent • Work location : Philip Morris Korea, Yangsan APPLICATION GUIDELINES • Click ‘Apply Now’ button and ‘Upload a File’ for new applicants • Upload your English Resume either in Word or PDF format (merge your files into one file named as your English name, i.e., CV_Gildong Hong) • Fill in basic information such as employment and education • Create password and submit application
  • Contract
    Full-Time
  • Location
    Yangsan, South Korea
  • Department
    Operations
  • Remaining Openings
    1
  • Job ID
    17023
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