Quality Engineer (f/m/d)
Avantor · Gliwice, Silesia, PL
The Opportunity: Avantor is looking for a meticulous and committed Quality Engineer to join our Quality Projects team at our key site in Gliwice.
Job description
The Opportunity: Avantor is looking for a meticulous and committed Quality Engineer to join our Quality Projects team at our key site in Gliwice. If you have experience in process validation, quality documentation, and want to make a real impact on product quality in the pharmaceutical, biotech, and research industries – this role is for you! Job Description: - Preparation & Execution of internal validation documentation. - Reviewing & Approval of external qualification documentation. - Contribute to the creation of Comparative Study Reports, Cause & Effects Matrix and Failure Modes Effects Analysis. - Determination of Critical Process Parameters and Critical Quality Attributes. - Training operating personnel and teams involved in validation execution. - Reviewing any deviations, CAPA’s, or amendments applicable to the validation documentation. - Reviewing all manufacturing and testing records for the completed lots under validation effort. - Support as subject matter expert during customer and regulatory inspections, reviews, and on-site meetings. - Contribute to the creation of SOP's and or instructions in the area of responsibility. - Support with Quality initiatives/investigati...