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Principal Quality Assurance Expert
3 weeks ago
Job Overview
We are seeking an experienced Senior QA Specialist to assume a pivotal role in our organization.
Key Responsibilities
- Lead the review and approval process for Change Controls, Deviations/CAPAs, SOPs, and related documentation, ensuring full compliance with GMP 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 quality 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.
