Job Description
You will collaborate with QA management personnel to implement and maintain the company's GxP Quality Systems, ensuring compliance and efficiency.
Daily Responsibilities:
You will assist in investigating quality system issues, conducting corrective and preventive actions (CAPA), and reviewing controlled documents such as Standard Operating Procedures (SOPs), deviations, and change controls.
You will participate in internal audits and walkthroughs to guarantee site compliance with Good Manufacturing Practices (GMP).
You will organize site training on quality management system elements, including GMP Induction and refresher courses.
Education and Experience:
A Bachelor's degree and at least 4 years of relevant experience in a GMP environment are required.
You should have a working knowledge of current Good Manufacturing Practices (cGMPs), including FDA and EMEA standards, and quality systems.
Familiarity with OPEX Lean tools and root cause analysis is also necessary for identifying and correcting deviations.