Validation Specialist

: Organize and coordinate site for M:ERP validation activities.

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Monitor/support on:going computer compliance

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Ensure gap analysis has been performed against global computerised system validation policies and issues have been resolved

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Provide and deliver training/mentoring for

M:ERP validation to all relevant site personnel

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Reviewing and Approving the validation plans and associated validation reports in accordance with QMS expectations, regulations associated with the markets supplied and, where required, local regulatory standards

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Perform periodic system reviews ensuring that the systems maintain their validated status

Requirements
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Knowledge in computerised systems and/or engineering

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Comprehensive knowledge of validation lifecycles for site systems (e.g. IT, Control Systems, Analytical Equipment, Spreadsheets, etc.)

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Comprehensive knowledge of GxP standards from local regulatory agencies for area of expertise

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Excellent organizational skills and ability to manage multiple priorities essential.

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Highly results oriented; ability to deliver and overcome obstacles.

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Excellent relationship and people skills along with a strong focus on the customer and a passion for exceptional customer service.

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Strongly developed communication skills both written and verbal.

Benefits
Contract position