Job Description
As a Quality Assurance Specialist, you will collaborate with QA management to implement and maintain the company's GxP Quality Systems.
Daily Responsibilities:
* Support investigations and corrective actions related to quality systems.
* Contribute to authoring, reviewing, and approving Standard Operating Procedures (SOPs) and controlled documents.
* Participate in internal audits and site walkthroughs to ensure compliance with GMP regulations.
* Organize training on QMS elements such as GMP Induction and Refresher programs.
Educational Requirements:
* 4+ years of experience in a GMP environment with a Bachelor's degree.
* Working knowledge of current Good Manufacturing Practices (cGMPs) including FDA and EMEA standards.
* Understanding of OPEX Lean tools and root cause analysis techniques.
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