Job Position : ܱ Ƿ̿ Validation Engineer 븮~  


-Generate validation documentation including DV, IQ, OQ, PQ protocols and validation reports, and assist in the execution of protocols.

-Design, generate and execute test plans and test protocols ,managing and reporting findings and non-conformances.

-Maintain consistency on validation/qualification approach across projects, ensuring validation documentation is fully compliant with site specific policies/procedures and regulations, good manufacturing practice and industry regulations.

-Be supportive of and encouraging of others in the project team, showing flexibility in the delivery of team results

-Engaging with cross functional teams to deliver process validation objectives in compliance with regulations and procedures.

-Responsibility for delivery of project timelines.

-Ensure all project related issues and deviations are documented and approved.

-Makes decisions under conditions of uncertainty, sometimes with incomplete information, that produce effective end results. Applies risk assessment techniques in such circumstances.

-Independently performs assignments with instruction limited to results expected. Determines and develops approach to solutions.


Validaiton (CSV )  
Calibration Management 

 . A minimum of 3 years experience in a validation role in a pharmaceutical or medical device industry.

 . In depth knowledge of relevant laws and regulations associated with the medical device industry (including FDA 21CFR regulations/ CE)

 . Competent working knowledge of recognized Quality Management Systems (ISO9001/ ISO13485/ ISO14971/ GMP)

 . Working experience of validation computer systems for use in FDA regulated environments. 

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 (Intermediate Level)

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E-mail : ******@*******.***

Phone : 010-3235-2771 / 02-3472-2550