Senior Quality Assurance Specialist
This is an exciting opportunity to drive quality assurance activities and ensure compliance with regulatory expectations.
Key Responsibilities:
* Lead the review and approval process for Change Controls, Deviations/CAPAs, SOPs, and related documentation, ensuring full compliance with GMP and site-specific requirements.
* Manage operational duties related to product disposition, ensuring timely and compliant decision-making.
* Monitor and evaluate new regulatory guidance and industry best practices, assessing their impact on quality systems and driving necessary updates.
* Assist in developing and maintaining QA policies, SOPs, and reports that support site operations and compliance.
* Champion continuous improvement initiatives by identifying opportunities to enhance quality processes and operational efficiencies.
* Participate in risk management activities, applying relevant guidance and industry best practices to mitigate potential quality risks.
* Support and execute the internal audit program, including conducting audits as required to ensure ongoing compliance and improvement.
Requirements:
* Degree in Science, Quality, or a related Technical field.
* 5-10 years of experience in Quality Assurance, Quality Control, or Technical Operations within FDA/EMEA regulated environments.
* Hands-on experience with quality management systems such as Veeva, SAP, PAS-X, or similar platforms
In this role, you will have the opportunity to contribute to the development and implementation of quality strategies that drive business success. If you are a motivated professional with a passion for quality assurance, we encourage you to apply.