Job Summary Responsibility Coordinate and lead equipment qualification Assist with the execution of validation / qualification protocols Reviewing of qualification documentation provided by external companies for scales and measuring equipment.
Interface with production systems service on all matters related to quality, process validation / qualification / system issues.
Subject matter expert during customer and regulatory inspections, reviews, and on-site meetings. Facilitate closure of production systems issues Support with Quality initiatives / investigations / risk assessments Working in compliance with current good manufacturing practice Supervision and Independent calibration of scales located production (analytical, technical, and industrial balances), Preparing and management of metrological documentation Requirements Degree in Engineering or related discipline Trusted weights systems knowledge (nice to have) Experience in supervision and calibration of scales Fluent English and Polish language skills (min.
level of B2) Good Manufacturing Practice knowledge Knowledge of CFR 21 part 11, PN-EN ISO 14253-1, preferable ISO / TS 16949, PN-EN ISO 10012, PN-EN ISO / IEC 17025 Very good working knowledge of MS Office High level of organizational skills and attention to detail .
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