QA Specialist

A pharmaceutical company is actively seeking a new QA Specialist to play a critical role in supporting External Quality Assurance Operations for late-stage programs (gene therapy), ensuring compliance with organization procedures, Quality Agreement, and regulatory requirements.

Responsibilities :

• Review and assess internal and external deviations related to manufacturing, and testing
• Ensure thorough root cause analysis and effective CAPA implementation
• Collaborate with stakeholders to drive timely closure and continuous improvement
• Perform executed batch record review ensuring completeness, accuracy, and compliance with regulatory expectations
• Provide real-time QA support during manufacturing and aseptic processing operations, including oversight of critical steps and data integrity verification
• Review and approve change controls and notifications, ensuring appropriate risk assessments and impact evaluations are conducted
• Ensure changes are implemented in a controlled and compliant manner, aligned with internal program milestones and regulatory commitments
• Partner with Manufacturing, MS&T, QC, Regulatory Affairs, and Supply Chain to ensure alignment on quality expectations and timely issue resolution
• Contribute to the development and refinement of QA procedures, templates, and best practices tailored to support GMP operations
• Identify and implement process improvements to enhance compliance and operational efficiency

Qualifications :

Desired Skills :

Experience with Biologics or Gene Therapy products