Quality Assurance Specialist

Quality Assurance Specialist

The QA Specialist's responsibilities will be as follows:

1. Deviations Management:

Investigate and manage deviations from established procedures, ensuring swift resolution and meticulous documentation.

2. Internal Audits:

Plan, conduct, and report on internal audits to guarantee adherence to regulatory requirements and uphold internal quality standards.

3. Nonconformities Addressing:

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

4. CAPA Leadership:

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

5. Critical Supplier

Collaboration:

Collaborate with cross-functional teams to manage critical suppliers, ensuring their adherence to rigorous quality standards.

6. Document Control (Veeva Vault):

Oversee document control activities using Veeva Vault, including document revisions, approvals, and maintenance to uphold regulatory compliance.

7. Change Control Evaluation:

Evaluate and manage change controls, ensuring seamless implementation in accordance with regulatory requirements.

8. Mock Batch Recall Reports:

Contribute to the preparation and execution of mock batch recall reports to assess and enhance the effectiveness of our recall procedures.

Qualifications:

Bachelor's degree in a relevant scientific field.

Proven experience in quality assurance within the biopharmaceutical or cell therapy industry.

In-depth knowledge of regulatory requirements and quality standards.