Job Overview: As a Senior Quality Assurance Specialist, you will lead the quality review and approval process for change controls, deviations/CAPAs, SOPs, and related documentation to ensure full compliance with GMP and regulatory requirements.
About the Role:
* Manage quality 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.
* Strong written and verbal communication skills, capable of clearly articulating complex quality issues.
* Logical thinker with the ability to remain proactive and composed under pressure.
* Proven ability to work effectively both independently and collaboratively within a team.
* Exceptional attention to detail and precision in preparing and reviewing GMP documentation