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CSV Engineer ¸ðÁý

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CSV Engineer ¸ðÁý

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CVS 

Engineer 

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¡á 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.

 


¡á 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

 


¡á Terms of Employment

Contract Type : Permanent

Work location : Philip Morris Korea, Yangsan


 

¡á 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 

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  • - Á¢¼ö±â°£ : 2019.07.05 ~ 2019.08.04±îÁö
  • - Á¢¼ö¹æ¹ý : ȨÆäÀÌÁöÁö¿ø(https://www.pmi.com/careers/job-details?id=17023)

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