Senior Quality Assurance Expert
This is an exciting opportunity to take on a key role in our quality assurance activities. As a senior quality assurance expert, you will be responsible for ensuring that all operations align with regulatory expectations and industry best practices.
Key Responsibilities:
* Lead the review and approval process for change controls, deviations/corrective actions, SOPs, and related documentation, ensuring full compliance with regulatory requirements and company policies.
* Manage quality operational duties related to product disposition, ensuring timely and compliant decision-making.
* Monitor and evaluate new regulatory guidance and industry developments, assessing their impact on quality systems and driving necessary updates.
* Assist in developing and maintaining quality policies, SOPs, and reports that support business 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.
Required Skills and Qualifications:
* Degree in Science, Quality, or a related Technical field.
* 5-10 years of experience in Quality Assurance, Quality Control, or Technical Operations within regulated environments.
* Hands-on experience with quality management systems such as Veeva, SAP, PAS-X, or similar platforms.
Benefits:
This role offers a unique opportunity to contribute to a dynamic and growing organization. If you are a motivated and experienced quality professional looking to make a meaningful impact, we encourage you to apply.