Job Description
As a QA Specialist, you will support the Quality Assurance management team in maintaining and executing the company's Good eXtensible Practices (GxP) Quality Systems.
Daily Responsibilities:
You will participate in the administration of the GxP Quality Systems, including Document Control, Training Programs, Deviations, and Corrective Actions.
Manage and maintain GxP documentation, such as audit files, raw data, reports, batch records, training records, deviations, and corrective actions.
Participate in internal audits and walkthroughs on behalf of the Quality Assurance department to ensure site compliance with Good Manufacturing Practices (GMP).
Coordinate and provide site training on Quality Management System (QMS) elements, including GMP Induction and Refresher training.
Requirements:
Knowledge of current Good Manufacturing Practices (cGMPs), adhering to FDA and EMEA standards and quality systems.
Familiarity with OPEX Lean tools and root cause analysis methods for identifying and correcting deviations.
At least 4 years of experience in a GMP environment related field, with a Bachelor's degree.
We are an employment agency and references to salary rates are indicative.
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