Job Description:
As a QA Specialist, you will collaborate with the QA management team to maintain and execute the company's GxP Quality Systems.
Daily Responsibilities:
You will participate in administering the company's GxP Quality Systems, including Document Control, Training Programs, Deviations, and Corrective Action Preventative Actions (CAPA).
Manage GxP documentation, such as audit files, raw data, reports, batch records, training records, and deviations.
Participate in internal audits and site walkthroughs to ensure compliance with Good Manufacturing Practices (GMP).
Coordinate and provide site training on Quality Management System (QMS) elements, including GMP Induction and Refresher courses.
Education and Experience:
Knowledge of current Good Manufacturing Practices (cGMPs) and quality systems, adhering to FDA and EMEA standards.
Understanding of OPEX Lean tools and root cause analysis techniques for identifying and correcting deviations.
4+ years of experience in a GMP environment-related field, accompanied by a Bachelor's degree.
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