Quality Assurance Specialist

Exciting Opportunity: Quality Assurance Specialist in Cell Therapy

Join our client, a dynamic company dedicated to Cell Therapy, and step into the role of a Quality Assurance Specialist. Your mission is to ensure the highest standards of quality and regulatory compliance in this rapidly growing field.

Responsibilities:

1. Deviations Management:

• Investigate and meticulously manage deviations from established procedures, ensuring swift resolution and thorough documentation.

1. Internal Audits:

• Plan, execute, and report on internal audits, guaranteeing strict adherence to regulatory requirements and internal quality standards.

1. Nonconformities Addressing:

• Identify, assess, and effectively address nonconformities, implementing corrective actions to prevent recurrence and elevate overall product quality.

1. CAPA Leadership:

• Take charge of the Corrective and Preventive Actions (CAPA) process, including root cause analysis, strategic corrective action planning, and verification of effectiveness.

1. Critical Supplier Collaboration:

• Collaborate with cross-functional teams to oversee critical suppliers, ensuring their alignment with rigorous quality standards.

1. Document Control (Veeva Vault):

• Manage document control activities using Veeva Vault, including document revisions, approvals, and maintenance to maintain regulatory compliance.

1. Change Control Evaluation:

• Evaluate and oversee change controls, ensuring seamless implementation in line with regulatory requirements.

1. Mock Batch Recall Reports:

• Contribute to the preparation and execution of mock batch recall reports, assessing and improving the effectiveness of our recall procedures.

Requirements

Qualifications:

• Bachelor's degree in a relevant scientific field.
• Proven experience in Quality Assurance within the biopharmaceutical or cell therapy industry.
• Comprehensive knowledge of regulatory requirements and quality standards.