Job Position : ¿Ü±¹°è ÀÇ·á¹ÙÀÌ¿ÀÁ¦¾à»ç Validation Engineer ´ë¸®~°úÂ÷Àå
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-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.
¤ýValidaiton (CSV Æ÷ÇÔ) °æ·ÂÀÚ
¤ýCalibration Management °æ·Â
. 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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¤ýMAXIMO »ç¿ë °æÇè
¤ý¿µ¾î °¡´ÉÀÚ (Intermediate Level)
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E-mail : ******@*******.***
Phone : 010-3235-2771 / 02-3472-2550