QA Lead - Sterile Fill Start-up & Compliance

BioMarin Pharmaceutical Inc.; Cork; On-site; EUR 55,000 - 70,000; Full time

Job summary

BioMarin Pharmaceutical Inc. is seeking a QA Associate to support the start-up of sterile filling operations at the Shanbally facility. This contract role will report to the QA Operations Manager and transition to routine QA support, promoting quality across cross-functional teams.

The candidate will ensure GMP compliance, assist with deviations and CAPAs, and contribute to regulatory readiness while coordinating with multiple departments. Shift work is required.

Qualifications

• Degree or 3rd level qualification in Science or Quality.
• QP Qualification would be an advantage.
• Demonstrated experience in Sterile Drug Product Filling and start-up is preferred.
• Demonstrates knowledge of FDA/EMEA regulations and quality systems.
• Proven ability to work independently and drive improvement initiatives.

Responsibilities

• Provide Quality direction and oversight of start-up, technical transfer, operation, and continuous improvement of Sterile Drug Product Filling operations.
• Provide Quality input to Change Controls, Protocols and Reports ensuring clear scope and timely implementation.
• Write, review and approve GMP documentation including SOPs, WIs, MTAs and batch records.
• Participate in cross-functional project teams to address issues in real time and help meet timelines.
• Lead CAPA closure and root cause analyses to address deviations and ensure compliance.

Skills

Quality Assurance

GMP Compliance

Documentation

Root Cause Analysis

Cross-functional Collaboration

Education

Bachelor's degree in Science or Quality

QP Qualification advantageous

Tools

Excel

Word

PowerPoint

Job description

BioMarin Pharmaceutical Inc. is seeking a QA Associate to support the start-up of sterile filling operations at the Shanbally facility. This contract role will report to the QA Operations Manager and transition to routine QA support, promoting quality across cross-functional teams.

The candidate will ensure GMP compliance, assist with deviations and CAPAs, and contribute to regulatory readiness while coordinating with multiple departments. Shift work is required.